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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: N

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with N, grouped by the NDA number the list gives.

FDA capture · 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 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

Nabumetone

NDA 019583 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 500 mg and 750 mg

    RLD/NDA as listed: Relafen 19583
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Naftifine Hydrochloride

NDA 204286 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.02

    RLD/NDA as listed: Naftin Gel 204286
    First PIV submission
    4 Feb 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    13 Aug 2019
    First applicant approval
    10 Apr 2019
    First marketing
    12 Apr 2023
    Last qualifying patent expiry (as listed by FDA)
    31 Jan 2033

Nalmefene Hydrochloride

NDA 217470 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 2.7 mg/spray

    RLD/NDA as listed: Opvee 217470
    First PIV submission
    7 Apr 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jul 2038

Naloxegol

NDA 204760 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 12.5 mg and 25 mg

    RLD/NDA as listed: Movantik 204760
    First PIV submission
    17 Sep 2018
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Apr 2032

Naloxone Hydrochloride

NDA 208411 · 2 rows · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 2 mg/spray

    RLD/NDA as listed: Narcan 208411
    First PIV submission
    28 Dec 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Dec 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Mar 2035

  • Nasal Spray · 4 mg/spray

    RLD/NDA as listed: Narcan 208411
    First PIV submission
    15 Jul 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    19 Apr 2019
    First marketing
    22 Dec 2021
    Last qualifying patent expiry (as listed by FDA)
    16 Mar 2035

Naloxone Hydrochloride

NDA 212045 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 8 mg/spray

    RLD/NDA as listed: Kloxxado 212045
    First PIV submission
    30 Mar 2023
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    12 May 2025
    First applicant approval
    24 Apr 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Aug 2034

Naltrexone

NDA 021897 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Injectable Suspension · 380 mg/vial

    RLD/NDA as listed: Vivitrol 21897
    First PIV submission
    18 Jun 2020
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Aug 2023
    First applicant approval
    6 Jul 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Oct 2029

Naltrexone Hydrochloride and Bupropion Hydrochloride

NDA 200063 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 8 mg/90 mg

    RLD/NDA as listed: Contrave 200063
    First PIV submission
    12 Mar 2015
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Feb 2030

Naproxen and Esomeprazole Magnesium

NDA 022511 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 375 mg/20 mg and 500 mg/20 mg

    RLD/NDA as listed: Vimovo 22511
    First PIV submission
    5 Nov 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Feb 2023

Naproxen Sodium

NDA 020353 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 375 mg (base) and 500 mg (base)

    RLD/NDA as listed: Naprelan 20353
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Naproxen Sodium

NDA 021920 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 200 mg

    RLD/NDA as listed: Naproxen Sodium 21920
    First PIV submission
    15 Nov 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Mar 2026

Naproxen Sodium and Sumatriptan Succinate

NDA 021926 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 500 mg/85 mg

    RLD/NDA as listed: Treximet 21926
    First PIV submission
    23 Jul 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Oct 2025

Nateglinide

NDA 021204 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 60 mg and 120 mg

    RLD/NDA as listed: Starlix 21204
    First PIV submission
    22 Dec 2004
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nebivolol Hydrochloride

NDA 021742 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg, 5 mg, 10 mg, and 20 mg

    RLD/NDA as listed: Bystolic 21742
    First PIV submission
    19 Dec 2011
    ANDAs
    7
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    16 Apr 2015
    First marketing
    17 Sep 2021
    Last qualifying patent expiry (as listed by FDA)
    17 Dec 2021

Nebivolol Hydrochloride and Valsartan

NDA 206302 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg/80 mg

    RLD/NDA as listed: Byvalson 206302
    First PIV submission
    9 Jun 2017
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    4 Oct 2022
    First applicant approval
    19 Sep 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Oct 2027

Nefazodone Hydrochloride

NDA 020152 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg, 100 mg, 150 mg, 200 mg and 250 mg

    RLD/NDA as listed: Serzone 20152
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nepafenac

NDA 203491 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Suspension · 3.0000000000000001E-3

    RLD/NDA as listed: Ilevro 203491
    First PIV submission
    21 Dec 2015
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Mar 2032

Neratinib Maleate

NDA 208051 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg

    RLD/NDA as listed: Nerlynx 208051
    First PIV submission
    19 Jul 2021
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Dec 2030

Netarsudil Mesylate

NDA 208254 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 2.0000000000000001E-4

    RLD/NDA as listed: Rhopressa 208254
    First PIV submission
    20 Dec 2021
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Mar 2034

Nevirapine

NDA 201152 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 400 mg

    RLD/NDA as listed: Viramune XR 201152
    First PIV submission
    21 Jun 2013
    ANDAs
    3
    180-day status
    Eligible
    Decision posted
    13 Dec 2022
    First applicant approval
    3 Apr 2014
    First marketing
    15 Apr 2014
    Last qualifying patent expiry (as listed by FDA)
    12 Mar 2029

Niacin

NDA 020381 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 500 mg, 750 mg and 1000 mg

    RLD/NDA as listed: Niaspan 20381
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nicardipine Hydrochloride

NDA 019734 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 0.1 mg/mL, 200 mL 0.2mg/mL, 200 mL

    RLD/NDA as listed: Cardene in 0.86% Sodium Chloride in plastic container and Cardene 0.83% Sodium Chloride in plastic container 19734
    First PIV submission
    9 Jan 2013
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    13 May 2024
    First applicant approval
    17 Apr 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2027

  • Injection · 2.5 mg/mL, 10 mL Ampoules

    RLD/NDA as listed: Cardene 19734
    First PIV submission
    27 Dec 2006
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nicotine

NDA 020076 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 7 mg/day, 14 mg/day 21 mg/day

    RLD/NDA as listed: Habitrol 20076
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nicotine

NDA 020165 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 7 mg/24 hrs 14 mg/24 hrs 21 mg/24 hrs

    RLD/NDA as listed: Nicoderm CQ 20165
    First PIV submission
    30 May 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 May 2021

Nicotine Polacrilex

NDA 022360 · 1 row · Listed patents and exclusivities · Open in the app

  • Troche/Lozenge (Mini) · 2 mg and 4 mg

    RLD/NDA as listed: Nicorette 22360
    First PIV submission
    2 Dec 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Oct 2019
    First applicant approval
    7 Feb 2019
    First marketing
    4 Apr 2019
    Last qualifying patent expiry (as listed by FDA)
    14 Jun 2029

Nifedipine

NDA 018482 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg and 20 mg

    RLD/NDA as listed: Procardia 18482
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nifedipine

NDA 019684 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 30 mg, 60 mg and 90 mg

    RLD/NDA as listed: Procardia XL 19684
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nifedipine

NDA 020198 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 30 mg, 60 mg and 90 mg

    RLD/NDA as listed: Adalat CC 20198
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nilotinib

NDA 022068 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 150 mg and 200 mg

    RLD/NDA as listed: Tasigna 22068
    First PIV submission
    8 Nov 2013
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    10/3/2024 1/8/2024
    First applicant approval
    5 Jan 2024
    First marketing
    23 May 2025
    Last qualifying patent expiry (as listed by FDA)
    23 Aug 2028

  • Capsules · 50 mg

    RLD/NDA as listed: Tasigna 22068
    First PIV submission
    17 Oct 2019
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    10/3/2024 1/8/2024
    First applicant approval
    5 Jan 2024
    First marketing
    23 May 2025
    Last qualifying patent expiry (as listed by FDA)
    7 Apr 2032

Nimodipine

NDA 203340 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 6 mg/mL

    RLD/NDA as listed: Nymalize 203340
    First PIV submission
    29 Nov 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Apr 2038

Nintedanib Esylate

NDA 205832 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 100 mg and 150 mg

    RLD/NDA as listed: Ofev 205832
    First PIV submission
    15 Oct 2018
    ANDAs
    4
    180-day status
    Extinguished
    Decision posted
    19 Mar 2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jun 2029

Niraparib Tosylate

NDA 214876 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg, 200 mg and 300 mg

    RLD/NDA as listed: Zejula 214876
    First PIV submission
    17 Jun 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jan 2039

Nisoldipine

NDA 020356 · 4 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 20 mg and 30 mg

    RLD/NDA as listed: Sular 20356
    First PIV submission
    7 Nov 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    25 Jul 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Jun 2008

  • Extended-release Tablets · 25.5 mg and 34 mg

    RLD/NDA as listed: Sular 20356
    First PIV submission
    28 Nov 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    26 Jan 2011
    First marketing
    28 Jan 2011
    Last qualifying patent expiry (as listed by FDA)
    30 Nov 2014

  • Extended-release Tablets · 40 mg

    RLD/NDA as listed: Sular 20356
    First PIV submission
    11 Jun 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    25 Jul 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Jun 2008

  • Extended-release Tablets · 8.5 mg and 17 mg

    RLD/NDA as listed: Sular 20356
    First PIV submission
    2 Mar 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    26 Jan 2011
    First marketing
    28 Jan 2011
    Last qualifying patent expiry (as listed by FDA)
    6 Jun 2012

Nitric Oxide

NDA 020845 · 1 row · Listed patents and exclusivities · Open in the app

  • for Inhalation · 100 ppm and 800 ppm

    RLD/NDA as listed: INOmax 20845
    First PIV submission
    20 May 2014
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    19 Nov 2019
    First applicant approval
    2 Oct 2018
    First marketing
    1 Apr 2019
    Last qualifying patent expiry (as listed by FDA)
    6 Jan 2031

Nitrofurantoin Monohydrate/ Macrocrystals

NDA 020064 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 75 mg/25 mg

    RLD/NDA as listed: Macrobid 20064
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nitroglycerin

NDA 018705 · 1 row · Listed patents and exclusivities · Open in the app

  • Sublingual Spray · 400 mcg/spray, 4.9 g and 12 g bottles

    RLD/NDA as listed: Nitrolingual Pumpspray 18705
    First PIV submission
    17 Apr 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    20 Sep 2013
    First marketing
    23 Sep 2013
    Last qualifying patent expiry (as listed by FDA)
    14 Mar 2028

Nitroglycerin

NDA 020144 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.1 mg/hr

    RLD/NDA as listed: Transderm-Nitro 20144
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nitroglycerin

NDA 020145 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.1 mg/hr 0.2 mg/hr 0.3 mg/hr 0.4 mg/hr 0.6 mg/hr 0.8 mg/hr

    RLD/NDA as listed: Nitro-dur 20145
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nitroglycerin

NDA 021134 · 1 row · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 0.3 mg, 0.4 mg, and 0.6 mg

    RLD/NDA as listed: Nitrostat 21134
    First PIV submission
    19 Oct 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Sep 2018

Nizatidine

NDA 019508 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 150 mg and 300 mg

    RLD/NDA as listed: Axid 19508
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nizatidine

NDA 021494 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 15 mg/mL

    RLD/NDA as listed: Axid 21494
    First PIV submission
    14 May 2008
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    4/18/2023 2/22/2022
    First applicant approval
    18 Nov 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Jul 2022

Norelgestromin and Ethinyl Estradiol

NDA 021180 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.15 mg/0.02 mg per 24 hours

    RLD/NDA as listed: Ortho Evra 21180
    First PIV submission
    22 Mar 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Nov 2015

Norephinephrine Bitartrate in 0.9% Sodium Chloride

NDA 215700 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 16 mg/250 mL

    RLD/NDA as listed: Norepinephrine Bitartrate in 0.9% Sodium Chloride 215700
    First PIV submission
    21 Jan 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Apr 2039

  • Norepinephrine Bitartrate in 0.9 % Sodium Chloride · Injection · 4 mg/250 mL and 8 mg/250 mL

    RLD/NDA as listed: Norepinephrine Bitartrate in 0.9 % Sodium Chloride 215700
    First PIV submission
    29 Sep 2023
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Apr 2039

Norepinephrine Bitartrate in 5% Dextrose

NDA 214313 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 16 mg/250 mL

    RLD/NDA as listed: Norepinephrine Bitartrate in 5% Dextrose 214313
    First PIV submission
    12 May 2025
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Apr 2026
    First applicant approval
    26 Mar 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Mar 2041

  • Norepinephrine Bitartrate in 5% Dextrose · Injection · 4 mg/250 mL and 8 mg/250 mL

    RLD/NDA as listed: Norepinephrine Bitartrate in 5% Dextrose 214313
    First PIV submission
    7 Oct 2024
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Mar 2026
    First applicant approval
    11 Aug 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Mar 2041

Norethindrone Acetate and Ethinyl Estradiol / Ethinyl Estradiol and Ferrous Fumarate

NDA 022501 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg/0.01 mg, 0.01 mg and 75 mg

    RLD/NDA as listed: Lo Loestrin Fe 22501
    First PIV submission
    29 Apr 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Feb 2029

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

NDA 203667 · 1 row · Listed patents and exclusivities · Open in the app

  • Chewable Tablets · 1 mg/0.02 mg and 75 mg

    RLD/NDA as listed: Minastrin 24 Fe 203667
    First PIV submission
    23 Apr 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Oct 2019
    First applicant approval
    24 May 2016
    First marketing
    15 Mar 2017
    Last qualifying patent expiry (as listed by FDA)
    6 Apr 2019

Norethindrone Acetate/ Ethinyl Estradiol

NDA 020130 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg/ 0.02 mg 1 mg/0.03 mg 1 mg /0.035 mg

    RLD/NDA as listed: Estrostep Fe 20130
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Tablets · 1 mg/0.02 mg 1 mg/ 0.03 mg and 1 mg /0.035 mg

    RLD/NDA as listed: Estrostep 21 20130
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Norethindrone Acetate/ Ethinyl Estradiol

NDA 021065 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg/0.005 mg

    RLD/NDA as listed: Femhrt 21065
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Norethindrone Acetate/ Ethinyl Estradiol and Ferrous Fumarate

NDA 021871 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg/0.02 mg and 75 mg

    RLD/NDA as listed: Loestrin 24 Fe 21871
    First PIV submission
    17 Apr 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    1 Sep 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2014

Norethindrone/ Ethinyl Estradiol

NDA 018985 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.5 mg/ 0.035 mg, 0.75 mg/ 0.035 mg and 1 mg /0.035 mg

    RLD/NDA as listed: Ortho-Novum 7/7/7, 21 and 28 day 18985
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Norgestimate/ Ethinyl Estradiol

NDA 019697 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg

    RLD/NDA as listed: Ortho Tri-Cyclen, 21 and 28 day 19697
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Norgestimate/ Ethinyl Estradiol

NDA 021241 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.18 mg /0.025 mg, 0.215 mg /0.025 mg and 0.25 mg /0.025 mg

    RLD/NDA as listed: Ortho Tri-Cyclen Lo, 28 day 21241
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nortriptyline Hydrochloride

NDA 018013 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg, 25 mg, 50 mg and 75 mg

    RLD/NDA as listed: Pamelor 18013
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Nusinersen

NDA 209531 · 1 row · Listed patents and exclusivities · Open in the app

  • Intrathecal Solution · 12 mg/5 mL

    RLD/NDA as listed: Spinraza 209531
    First PIV submission
    10 Mar 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Mar 2036