FDA Orange Book · active-ingredient family
Nitroglycerin
Nitroglycerin is approved as 14 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GONITRO · NDA 208424
14
Brand (NDA)
42
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, aerosol, metered, film, extended release, injectable, ointment, powder, spray, metered, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GONITRORLD | POHL BOSKAMP | NDA 208424 | — | Jun 08, 2016 | |
| RECTIVRLD | ABBVIE | NDA 021359 | — | Jun 21, 2011 | |
| NITROMISTRLD | EVUS | NDA 021780 | — | Nov 02, 2006 | |
| NITROSTATRLD×3 | VIATRIS | NDA 021134 | AB | May 01, 2000 | |
| NITROLINGUAL PUMPSPRAYRLD×2 | POHL BOSKAMP | NDA 018705 | AB | Jan 10, 1997 | |
| TRANSDERM-NITRORLD×5 | NOVARTIS | NDA 020144 | — | Feb 27, 1996 | |
| NITRO-DURRLD×6 | USPHARMA | NDA 020145 | — | Apr 04, 1995 | |
| NITROGLYCERIN IN DEXTROSE 5%RLD×3 | BAXTER HLTHCARE | NDA 019970 | — | Dec 29, 1989 | |
| NITROGLYCERINRLD | HOSPIRA | NDA 018531 | — | Approved Prior to Jan 1, 1982 | |
| NITRO IV×2 | POHL BOSKAMP | NDA 018672 | — | Aug 30, 1983 | |
| TRIDIL×2 | HOSPIRA | NDA 018537 | — | Jun 16, 1983 | |
| NITROL | RORER | NDA 018774 | — | Jan 19, 1983 | |
| NITRO-BID | SANOFI AVENTIS US | NDA 018621 | — | Jan 05, 1982 | |
| NITROSTAT×2 | PARKE DAVIS | NDA 018588 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (42)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NITROGLYCERIN | SOLARIS PHARMA CORP | ANDA 218756 | AB | Dec 18, 2025 | |
| NITROGLYCERIN | ENCUBE | ANDA 218235 | AB | Apr 15, 2025 | |
| NITROGLYCERIN | ENCUBE | ANDA 216452 | AB | Dec 16, 2024 | |
| NITROGLYCERIN | TP ANDA HOLDINGS | ANDA 212222 | AB | Nov 29, 2024 | |
| NITROGLYCERIN×3 | VIWIT PHARM | ANDA 218583 | AB | Oct 15, 2024 | |
| NITROGLYCERIN | COSETTE PHARMS NC | ANDA 216103 | AB | Feb 16, 2024 | |
| NITROGLYCERIN×3 | MANKIND PHARMA | ANDA 217970 | AB | Dec 05, 2023 | |
| NITROGLYCERIN×3 | AUROBINDO PHARMA | ANDA 217879 | AB | Oct 26, 2023 | |
| NITROGLYCERIN×3 | ZYDUS PHARMS | ANDA 210153 | — | Mar 08, 2022 | |
| NITROGLYCERIN×3 | RUBICON RESEARCH | ANDA 209779 | AB | May 03, 2021 | |
| NITROGLYCERIN×3 | NATCO | ANDA 211604 | AB | Apr 30, 2019 | |
| NITROGLYCERIN×3 | SIGMAPHARM LABS LLC | ANDA 207745 | — | May 07, 2018 | |
| NITROGLYCERIN×2 | ZYDUS PHARMS | ANDA 089885 | AB2 | Oct 30, 2017 | |
| NITROGLYCERIN×3 | ACTAVIS LABS FL INC | ANDA 203693 | — | Oct 16, 2017 | |
| NITROGLYCERIN×3 | GLENMARK SPECLT | ANDA 206391 | AB | Sep 19, 2017 | |
| NITROGLYCERIN×3 | DR REDDYS | ANDA 208191 | AB | Aug 26, 2016 | |
| NITROGLYCERIN | PADAGIS ISRAEL | ANDA 091496 | AB | Sep 20, 2013 | |
| NITROGLYCERIN×2 | LANNETT CO INC | ANDA 075115 | — | Aug 10, 2004 | |
| NITROGLYCERIN×4 | MYLAN TECHNOLOGIES | ANDA 074992 | — | Nov 12, 1999 | |
| NITROGLYCERIN | ZYDUS PHARMS | ANDA 089884 | AB2 | Oct 30, 1998 | |
| NITROGLYCERIN | ZYDUS PHARMS | ANDA 089886 | AB2 | Oct 30, 1998 | |
| NITROGLYCERIN×4 | MYLAN TECHNOLOGIES | ANDA 074559 | AB2 | Feb 06, 1998 | |
| MINITRAN | BAUSCH | ANDA 089773 | — | Aug 30, 1996 | |
| MINITRAN | VALEANT PHARMS | ANDA 089771 | — | Aug 30, 1996 | |
| MINITRAN | VALEANT PHARMS | ANDA 089774 | — | Aug 30, 1996 | |
| MINITRAN | VALEANT PHARMS NORTH | ANDA 089772 | — | Aug 30, 1996 | |
| NITROGLYCERIN IN DEXTROSE 5% | HOSPIRA | ANDA 074083 | — | Oct 26, 1994 | |
| NITROGLYCERIN IN DEXTROSE 5% | HOSPIRA | ANDA 071846 | — | Aug 31, 1990 | |
| NITROGLYCERIN IN DEXTROSE 5% | HOSPIRA | ANDA 071847 | — | Aug 31, 1990 | |
| NITROGLYCERIN IN DEXTROSE 5% | HOSPIRA | ANDA 071848 | — | Aug 31, 1990 | |
| NITRO-BID | SANOFI AVENTIS US | ANDA 071159 | — | Feb 28, 1990 | |
| NITROGLYCERINRLD | FOUGERA PHARMS INC | ANDA 087355 | AB | Jul 08, 1988 | |
| NITROGLYCERIN | AM REGENT | ANDA 072034 | — | May 24, 1988 | |
| NITROGLYCERIN | LUITPOLD | ANDA 071492 | — | May 24, 1988 | |
| NITROGLYCERIN | ABRAXIS PHARM | ANDA 071203 | — | May 08, 1987 | |
| NITROSTAT | PARKE DAVIS | ANDA 070863 | — | Jan 08, 1987 | |
| NITROSTAT | PARKE DAVIS | ANDA 070871 | — | Jan 08, 1987 | |
| NITROSTAT | PARKE DAVIS | ANDA 070872 | — | Jan 08, 1987 | |
| NITROGLYCERIN | SMITH AND NEPHEW | ANDA 070633 | — | Jun 19, 1986 | |
| NITROGLYCERIN | SMITH AND NEPHEW | ANDA 070634 | — | Jun 19, 1986 | |
| NITROGLYCERIN | ABRAXIS PHARM | ANDA 070077 | — | Dec 13, 1985 | |
| NITROGLYCERIN | INTL MEDICATION | ANDA 070026 | — | Sep 10, 1985 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7872049 | Mar 12, 2029 | in 2 yr 9 mo | ProductU-2223 |
| 9101592 | Mar 11, 2032 | in 5 yr 10 mo | Product |
Nitroglycerin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
