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Drybench Patent.

FDA Paragraph IV list

Each row of FDA's Paragraph IV certifications list as captured on 17 October 2026, grouped by the NDA number the list gives, with a link to that NDA's listed patents and exclusivities in the app. Rows with no NDA number this page can match are kept apart at the end, with the reason.

FDA capture ยท review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.

Paragraph IV list captured
17 October 2026
Last checked
30 October 2026
Rows
1,571 rows under 1,215 NDAs; 76 kept apart
File
9-28-2026 Paragraph IV List (Public).xlsx
FDA file SHA-256
594a7003786f2cab1a9e08fd6ef450117597526109a36dd52dd70bebceb47654
Data-branch commit
dadcab56563716abea6c5e31a5e1970080c778ef

Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.

FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Paragraph IV certificationWhat changed, by week

Rows by drug name

  • A135 rows, 112 NDAs
  • B92 rows, 71 NDAs
  • C127 rows, 99 NDAs
  • D140 rows, 101 NDAs
  • E98 rows, 81 NDAs
  • F78 rows, 62 NDAs
  • G37 rows, 29 NDAs
  • H20 rows, 13 NDAs
  • I57 rows, 42 NDAs
  • K8 rows, 8 NDAs
  • L103 rows, 85 NDAs
  • M111 rows, 88 NDAs
  • N63 rows, 54 NDAs
  • O62 rows, 46 NDAs
  • P89 rows, 68 NDAs
  • Q9 rows, 4 NDAs
  • R74 rows, 55 NDAs
  • S64 rows, 51 NDAs
  • T135 rows, 94 NDAs
  • U7 rows, 5 NDAs
  • V47 rows, 35 NDAs
  • Z15 rows, 12 NDAs

Rows kept apart (76)

These rows are on FDA's list as captured but give no NDA number this page can match, so they are not placed under any NDA. Any of them may concern a product listed above. Each shows its data-line number and its cells as captured.

The RLD/NDA cell gives no number (63)

  • Data line 596

    DRUG NAME
    Famotidine
    DOSAGE FORM
    Injection
    STRENGTH
    10 mg/mL, 2 mL vials; unpreserved
    RLD/NDA
    Pepcid
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 597

    DRUG NAME
    Famotidine
    DOSAGE FORM
    Injection
    STRENGTH
    10 mg/mL, 4 mL and 20 mL vials; preserved
    RLD/NDA
    Pepcid
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 598

    DRUG NAME
    Famotidine
    DOSAGE FORM
    Injection
    STRENGTH
    10 mg/mL, 50 mL vial, pharmacy bulk package; unpreserved
    RLD/NDA
    Pepcid
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 599

    DRUG NAME
    Famotidine
    DOSAGE FORM
    Tablets
    STRENGTH
    10 mg (OTC)
    RLD/NDA
    Pepcid AC
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 688

    DRUG NAME
    Gatifloxacin
    DOSAGE FORM
    Injection
    STRENGTH
    10 mg/mL, 20 mL and 40 mL vials
    RLD/NDA
    Tequin
    DATE OF SUBMISSION
    11/24/2004
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43997
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 690

    DRUG NAME
    Gatifloxacin
    DOSAGE FORM
    Tablets
    STRENGTH
    200 mg and 400 mg
    RLD/NDA
    Tequin
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 692

    DRUG NAME
    Gatifloxacin in Dextrose 5% in Plastic Container
    DOSAGE FORM
    Injection
    STRENGTH
    2 mg/mL, 100 mL and 200 mL containers (plastic)
    RLD/NDA
    Tequin
    DATE OF SUBMISSION
    12/13/2004
    NUMBER OF ANDAs SUBMITTED
    2
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 694

    DRUG NAME
    Gemcitabine
    DOSAGE FORM
    For Injection
    STRENGTH
    2 g/vial
    RLD/NDA
    Gemzar
    DATE OF SUBMISSION
    8/24/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    43997
    DATE OF FIRST APPLICANTAPPROVAL
    40497
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    40497
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    41220

  • Data line 707

    DRUG NAME
    Glycopyrrolate
    DOSAGE FORM
    Tablets
    STRENGTH
    1.5 mg
    RLD/NDA
    Robinul Forte
    DATE OF SUBMISSION
    39939
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Deferred
    180-DAY DECISION POSTING DATE
    43997
    DATE OF FIRST APPLICANTAPPROVAL
    40980
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    45406

  • Data line 728

    DRUG NAME
    Hydrocodone Bitartrate and Ibuprofen
    DOSAGE FORM
    Tablets
    STRENGTH
    5 mg/200 mg
    RLD/NDA
    Vicoprofen
    DATE OF SUBMISSION
    5/27/2005
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    38064
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    42896

  • Data line 751

    DRUG NAME
    Ibuprofen
    DOSAGE FORM
    Oral Suspension
    STRENGTH
    100 mg/5 mL (OTC)
    RLD/NDA
    Children's Motrin
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 752

    DRUG NAME
    Ibuprofen
    DOSAGE FORM
    Oral Suspension
    STRENGTH
    100 mg/5 mL (Rx)
    RLD/NDA
    Motrin
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 755

    DRUG NAME
    Ibuprofen Potassium and Pseudoephedrine Hydrochloride
    DOSAGE FORM
    Capsules
    STRENGTH
    200 mg/30 mg
    RLD/NDA
    Advil Cold and Sinus
    DATE OF SUBMISSION
    12/27/2004
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44011
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 760

    DRUG NAME
    Ibuprofen and Pseudoephedrine Hydrochloride
    DOSAGE FORM
    Oral Suspension
    STRENGTH
    100 mg/ 15 mg per 5 mL
    RLD/NDA
    Children's Motrin Cold
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 761

    DRUG NAME
    Ibuprofen and Pseudoephedrine Hydrochloride
    DOSAGE FORM
    Tablets
    STRENGTH
    200 mg/30 mg
    RLD/NDA
    Advil Cold and Sinus
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 767

    DRUG NAME
    Ifosfamide
    DOSAGE FORM
    Injection
    STRENGTH
    50 mg/mL, 20 mL vials and 60 mL vials
    RLD/NDA
    Ifex
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 769

    DRUG NAME
    Ifosfamide/ Mesna
    DOSAGE FORM
    Injection/ Injection Kit
    STRENGTH
    50 mg/mL, 20 mL and 60 mL vials; 100 mg/mL, 10 mL vial
    RLD/NDA
    Ifex/ Mesnex Kit
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 771

    DRUG NAME
    Imatinib Mesylate
    DOSAGE FORM
    Capsules
    STRENGTH
    400 mg
    RLD/NDA
    Gleevec
    DATE OF SUBMISSION
    41663
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43900
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43481

  • Data line 822

    DRUG NAME
    Lamivudine
    DOSAGE FORM
    Tablets
    STRENGTH
    100 mg
    RLD/NDA
    Epivir-HBV
    DATE OF SUBMISSION
    10/31/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43900
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    42508

  • Data line 823

    DRUG NAME
    Lamivudine
    DOSAGE FORM
    Tablets
    STRENGTH
    150 mg and 300 mg
    RLD/NDA
    Epivir
    DATE OF SUBMISSION
    10/16/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44474
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    40134

  • Data line 824

    DRUG NAME
    Lamivudine
    DOSAGE FORM
    Oral Solution
    STRENGTH
    10 mg/mL
    RLD/NDA
    Epivir
    DATE OF SUBMISSION
    40869
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    44292
    DATE OF FIRST APPLICANTAPPROVAL
    41943
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    42068
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43179

  • Data line 825

    DRUG NAME
    Lamivudine and Zidovudine
    DOSAGE FORM
    Tablets
    STRENGTH
    150 mg/300 mg
    RLD/NDA
    Combivir
    DATE OF SUBMISSION
    6/26/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    44474
    DATE OF FIRST APPLICANTAPPROVAL
    40688
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    40942
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    42508

  • Data line 917

    DRUG NAME
    Lovastatin and Niacin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    20 mg/1000 mg
    RLD/NDA
    Advicor
    DATE OF SUBMISSION
    5/22/2008
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 918

    DRUG NAME
    Lovastatin and Niacin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    20 mg/500 mg
    RLD/NDA
    Advicor
    DATE OF SUBMISSION
    9/22/2008
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 919

    DRUG NAME
    Lovastatin and Niacin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    20 mg/750 mg
    RLD/NDA
    Advicor
    DATE OF SUBMISSION
    12/17/2008
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 920

    DRUG NAME
    Lovastatin and Niacin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    40 mg/1000 mg
    RLD/NDA
    Advicor
    DATE OF SUBMISSION
    11/19/2009
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,060

    DRUG NAME
    Niacin and Simvastatin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    1000 mg/20 mg
    RLD/NDA
    Simcor
    DATE OF SUBMISSION
    40073
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,061

    DRUG NAME
    Niacin and Simvastatin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    500 mg/20 mg
    RLD/NDA
    Simcor
    DATE OF SUBMISSION
    40221
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,062

    DRUG NAME
    Niacin and Simvastatin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    750 mg/20 mg
    RLD/NDA
    Simcor
    DATE OF SUBMISSION
    40226
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,063

    DRUG NAME
    Niacin and Simvastatin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    1000 mg/40 mg
    RLD/NDA
    Simcor
    DATE OF SUBMISSION
    40578
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,064

    DRUG NAME
    Niacin and Simvastatin
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    500 mg/40 mg
    RLD/NDA
    Simcor
    DATE OF SUBMISSION
    40583
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,069

    DRUG NAME
    Nicotine Polacrilex
    DOSAGE FORM
    Gum
    STRENGTH
    2 mg
    RLD/NDA
    Nicorette
    DATE OF SUBMISSION
    41296
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,070

    DRUG NAME
    Nicotine Polacrilex
    DOSAGE FORM
    Gum
    STRENGTH
    4 mg
    RLD/NDA
    Nicorette
    DATE OF SUBMISSION
    41296
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,071

    DRUG NAME
    Nicotine Polacrilex
    DOSAGE FORM
    Troche/Lozenge
    STRENGTH
    2 mg and 4 mg
    RLD/NDA
    Commit
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,105

    DRUG NAME
    Norethindrone and Ethinyl Estradiol and Ferrous Fumarate
    DOSAGE FORM
    Chewable Tablets
    STRENGTH
    0.8 mg/0.025 mg and 75 mg
    RLD/NDA
    Generess Fe
    DATE OF SUBMISSION
    40760
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    41752
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    42095
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43571

  • Data line 1,173

    DRUG NAME
    Oxycodone Hydrochloride and Acetaminophen
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    7.5 mg/325 mg
    RLD/NDA
    Xartemis XR
    DATE OF SUBMISSION
    41732
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44236
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    47838

  • Data line 1,176

    DRUG NAME
    Oxymorphone Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    30 mg
    RLD/NDA
    Opana ER
    DATE OF SUBMISSION
    6/12/2008
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    40381
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    41282
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44961

  • Data line 1,178

    DRUG NAME
    Oxymorphone Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    5 mg, 10 mg, 20 mg and 40 mg
    RLD/NDA
    Opana ER
    DATE OF SUBMISSION
    11/23/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    40343
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    20 mg- 1/3/2013 5 mg, 10 mg and 40 mg -1/8/2013
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44745

  • Data line 1,179

    DRUG NAME
    Oxymorphone Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    7.5 mg and 15 mg
    RLD/NDA
    Opana ER
    DATE OF SUBMISSION
    5/29/2008
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    40525
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44745

  • Data line 1,181

    DRUG NAME
    Ozanimod Hydrochloride
    DOSAGE FORM
    Capsules
    STRENGTH
    0.23 mg, 0.46 mg and 0.92 mg
    RLD/NDA
    Zeposia
    DATE OF SUBMISSION
    45376
    NUMBER OF ANDAs SUBMITTED
    3
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    50678

  • Data line 1,240

    DRUG NAME
    Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl
    DOSAGE FORM
    For Oral Solution and Delayed-release Tablets
    STRENGTH
    210 g, 5.6 g, 0.74 g, 2.86 g and 5 mg (2 Tablet Regimen)
    RLD/NDA
    Halflytely and Bisacodyl
    DATE OF SUBMISSION
    1/28/2008
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44614
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44856

  • Data line 1,241

    DRUG NAME
    Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl
    DOSAGE FORM
    For Oral Solution and Delayed-release Tablet
    STRENGTH
    210 g, 5.6 g, 0.74 g, 2.86 g and 5 mg (1 Tablet Regimen)
    RLD/NDA
    Halflytely and Bisacodyl
    DATE OF SUBMISSION
    40389
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    44614
    DATE OF FIRST APPLICANTAPPROVAL
    41871
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    42115
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44856

  • Data line 1,251

    DRUG NAME
    Potassium Chloride
    DOSAGE FORM
    Extended-release Capsules
    STRENGTH
    8 mEq and 10 mEq
    RLD/NDA
    Micro K
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,252

    DRUG NAME
    Potassium Chloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    10 mEq and 20 mEq
    RLD/NDA
    K-Dur
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,291

    DRUG NAME
    Ranitidine
    DOSAGE FORM
    Capsules
    STRENGTH
    150 mg and 300 mg
    RLD/NDA
    Zantac
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,292

    DRUG NAME
    Ranitidine
    DOSAGE FORM
    Injection
    STRENGTH
    25 mg/mL, 2 mL and 6 mL and 40 mL vials
    RLD/NDA
    Zantac
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,293

    DRUG NAME
    Ranitidine
    DOSAGE FORM
    Oral Solution
    STRENGTH
    15 mg/mL
    RLD/NDA
    Zantac
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,294

    DRUG NAME
    Ranitidine
    DOSAGE FORM
    Tablets
    STRENGTH
    75 mg, 150 mg and 300 mg
    RLD/NDA
    Zantac
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,322

    DRUG NAME
    Risedronate Sodium with Calcium Carbonate
    DOSAGE FORM
    Tablets
    STRENGTH
    35 mg; 500 mg
    RLD/NDA
    Actonel with Calcium
    DATE OF SUBMISSION
    39434
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43900
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43298

  • Data line 1,328

    DRUG NAME
    Ritonavir
    DOSAGE FORM
    Capsules
    STRENGTH
    100 mg
    RLD/NDA
    Norvir
    DATE OF SUBMISSION
    41213
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44236
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43973

  • Data line 1,427

    DRUG NAME
    Sumatriptan Succinate
    DOSAGE FORM
    Injection
    STRENGTH
    6 mg/0.5 mL, 0.5 mL (prefilled syringes)
    RLD/NDA
    Imitrex
    DATE OF SUBMISSION
    5/9/2006
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43900
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    39666

  • Data line 1,428

    DRUG NAME
    Sumatriptan Succinate
    DOSAGE FORM
    Injection
    STRENGTH
    6 mg/0.5 mL, 0.5 mL vials
    RLD/NDA
    Imitrex
    DATE OF SUBMISSION
    10/25/2004
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44067
    DATE OF FIRST APPLICANTAPPROVAL
    40095
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    39666

  • Data line 1,468

    DRUG NAME
    Terfenadine
    DOSAGE FORM
    Tablets
    STRENGTH
    60 mg
    RLD/NDA
    Seldane
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,471

    DRUG NAME
    Testosterone
    DOSAGE FORM
    Gel
    STRENGTH
    1%
    RLD/NDA
    Androgel
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,473

    DRUG NAME
    Testosterone
    DOSAGE FORM
    Gel
    STRENGTH
    1.62% (pump)
    RLD/NDA
    Androgel
    DATE OF SUBMISSION
    41005
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    43746
    DATE OF FIRST APPLICANTAPPROVAL
    42220
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    43385
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44073

  • Data line 1,475

    DRUG NAME
    Testosterone
    DOSAGE FORM
    Gel
    STRENGTH
    1% (pump)
    RLD/NDA
    Androgel
    DATE OF SUBMISSION
    39801
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44067
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    44256

  • Data line 1,486

    DRUG NAME
    Ticlopidine Hydrochloride
    DOSAGE FORM
    Tablets
    STRENGTH
    250 mg
    RLD/NDA
    Ticlid
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,487

    DRUG NAME
    Tigecycline
    DOSAGE FORM
    For Injection
    STRENGTH
    50 mg per vial
    RLD/NDA
    Tygacil
    DATE OF SUBMISSION
    39979
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44067
    DATE OF FIRST APPLICANTAPPROVAL
    42151
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    42469

  • Data line 1,488

    DRUG NAME
    Timolol Maleate
    DOSAGE FORM
    Ophthalmic Solution
    STRENGTH
    0.25% and 0.5%
    RLD/NDA
    Timoptic
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,564

    DRUG NAME
    Tretinoin
    DOSAGE FORM
    Cream
    STRENGTH
    0.025%, 0.05% and 0.1%
    RLD/NDA
    Retin-A
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,568

    DRUG NAME
    Triamcinolone Acetonide
    DOSAGE FORM
    Nasal Spray
    STRENGTH
    0.055 mg/Spray
    RLD/NDA
    Nasacort AQ
    DATE OF SUBMISSION
    12/29/2005
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Deferred
    180-DAY DECISION POSTING DATE
    44053
    DATE OF FIRST APPLICANTAPPROVAL
    40024
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    42554

  • Data line 1,610

    DRUG NAME
    Verapamil Hydrochloride
    DOSAGE FORM
    Extended-release Capsules
    STRENGTH
    120 mg, 180 mg and 240 mg
    RLD/NDA
    Verelan SR
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,612

    DRUG NAME
    Verapamil Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    180 mg
    RLD/NDA
    Isoptin SR
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

The RLD/NDA cell does not give exactly one number of four to six digits (2)

  • Data line 1,104

    DRUG NAME
    Norethindrone and Ethinyl Estradiol and Ferrous Fumarate
    DOSAGE FORM
    Chewable Tablets
    STRENGTH
    0.4 mg/0.035 mg
    RLD/NDA
    Ovcon-35 Fe Femcon Fe NDA 21-490
    DATE OF SUBMISSION
    4/27/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Non-Forfeiture
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    40395
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    40627
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43561

  • Data line 1,366

    DRUG NAME
    Safinamide Mesylate
    DOSAGE FORM
    Tablets
    STRENGTH
    50 mg and 100 mg
    RLD/NDA
    Xadago 2071454
    DATE OF SUBMISSION
    44277
    NUMBER OF ANDAs SUBMITTED
    6
    180-DAY STATUS
    Eligible
    180-DAY DECISION POSTING DATE
    45103
    DATE OF FIRST APPLICANTAPPROVAL
    45091
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    47097

The number given matches no NDA with products in this Orange Book capture (11)

  • Data line 335

    DRUG NAME
    Colestipol Hydrochloride
    DOSAGE FORM
    Tablets
    STRENGTH
    1 g
    RLD/NDA
    Colestid 02222
    DATE OF SUBMISSION
    8/23/2005
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    39014
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 404

    DRUG NAME
    Dexlansoprazole
    DOSAGE FORM
    Delayed-release Capsules
    STRENGTH
    60 mg
    RLD/NDA
    Dexilant 2287
    DATE OF SUBMISSION
    40415
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished Deferred
    180-DAY DECISION POSTING DATE
    9/20/2022 4/7/2020
    DATE OF FIRST APPLICANTAPPROVAL
    42844
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    44887
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    46236

  • Data line 740

    DRUG NAME
    Hydroxyprogesterone Caproate
    DOSAGE FORM
    Injection (Auto-injector)
    STRENGTH
    275 mg/1.1 mL
    RLD/NDA
    Makena 21945
    DATE OF SUBMISSION
    44102
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    49797

  • Data line 910

    DRUG NAME
    Lorcaserin Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    20 mg
    RLD/NDA
    Belviq XR 208524
    DATE OF SUBMISSION
    42717
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43970
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    48617

  • Data line 911

    DRUG NAME
    Lorcaserin Hydrochloride
    DOSAGE FORM
    Tablets
    STRENGTH
    10 mg
    RLD/NDA
    Belviq 22529
    DATE OF SUBMISSION
    42548
    NUMBER OF ANDAs SUBMITTED
    4
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    43970
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    48617

  • Data line 1,154

    DRUG NAME
    Oxandrolone
    DOSAGE FORM
    Tablets
    STRENGTH
    2.5 mg and 10 mg
    RLD/NDA
    Oxandrin 13718
    DATE OF SUBMISSION
    6/19/2006
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    43074

  • Data line 1,163

    DRUG NAME
    Oxycodone
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    10 mg, 20 mg, 40 mg, 80 mg and 160 mg
    RLD/NDA
    Oxycontin (NDA 020553)
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank

  • Data line 1,165

    DRUG NAME
    Oxycodone Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    15 mg
    RLD/NDA
    Oxycontin (NDA 020553)
    DATE OF SUBMISSION
    2/15/2007
    NUMBER OF ANDAs SUBMITTED
    2
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    41380

  • Data line 1,166

    DRUG NAME
    Oxycodone Hydrochloride
    DOSAGE FORM
    Extended-release Tablets
    STRENGTH
    30 mg and 60 mg
    RLD/NDA
    Oxycontin (NDA 020553)
    DATE OF SUBMISSION
    1/3/2007
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Extinguished
    180-DAY DECISION POSTING DATE
    44600
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    41380

  • Data line 1,228

    DRUG NAME
    Pioglitazone Hydrochloride and Metformin Hydrochloride
    DOSAGE FORM
    Tablets
    STRENGTH
    15 mg/500 mg and 15 mg/850 mg
    RLD/NDA
    Actoplus Met 21824
    DATE OF SUBMISSION
    3/6/2008
    NUMBER OF ANDAs SUBMITTED
    1
    180-DAY STATUS
    Non-Forfeiture Extinguished
    180-DAY DECISION POSTING DATE
    3/22/2022 3/22/2022
    DATE OF FIRST APPLICANTAPPROVAL
    40599
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    41138
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    42540

  • Data line 1,636

    DRUG NAME
    Zidovudine
    DOSAGE FORM
    Capsules
    STRENGTH
    100 mg
    RLD/NDA
    Retrovir 19665
    DATE OF SUBMISSION
    Pre-MMA
    NUMBER OF ANDAs SUBMITTED
    blank
    180-DAY STATUS
    blank
    180-DAY DECISION POSTING DATE
    blank
    DATE OF FIRST APPLICANTAPPROVAL
    blank
    DATE OF FIRST COMMERCIAL MARKETING BY FTF
    blank
    EXPIRATION DATE OF LAST QUALIFYING PATENT
    blank