FDA Orange Book · active-ingredient family
Nifedipine
Nifedipine is approved as 4 brand and 32 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADALAT CC · NDA 020198
4
Brand (NDA)
32
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADALAT CCRLD×3 | NORWICH | NDA 020198 | — | Apr 21, 1993 | |
| PROCARDIA XLRLD×3 | PFIZER | NDA 019684 | AB2 | Sep 06, 1989 | |
| PROCARDIARLD×2 | PFIZER | NDA 018482 | — | Approved Prior to Jan 1, 1982 | |
| ADALAT×2 | BAYER PHARMS | NDA 019478 | — | Nov 27, 1985 |
Generic (ANDA) products (32)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIFEDIPINE×3 | ALEMBIC | ANDA 216896 | AB2 | Nov 18, 2022 | |
| NIFEDIPINE×2 | PHARMADAX | ANDA 216019 | — | Nov 18, 2022 | |
| NIFEDIPINE×3 | ALKEM LABS LTD | ANDA 216067 | AB2 | Mar 29, 2022 | |
| NIFEDIPINE×3 | AUROBINDO PHARMA | ANDA 213361 | AB1 | Jul 19, 2021 | |
| NIFEDIPINE | ELITE PHARM SOLUTION | ANDA 212016 | AB2 | Nov 18, 2020 | |
| NIFEDIPINE×3 | SPIL | ANDA 210838 | — | Apr 16, 2019 | |
| NIFEDIPINE×3 | NOVAST LABS | ANDA 210614 | AB2 | Mar 12, 2019 | |
| NIFEDIPINE×3 | ZYDUS PHARMS | ANDA 210184 | AB1 | Jun 29, 2018 | |
| NIFEDIPINE×3 | ZYDUS PHARMS | ANDA 210012 | AB2 | Dec 19, 2017 | |
| NIFEDIPINE×3 | NOVAST LABS | ANDA 202987 | AB1 | Aug 25, 2016 | |
| NIFEDIPINE×3 | TWI PHARMS | ANDA 203126 | AB2 | Apr 03, 2014 | |
| NIFEDIPINE×2 | HERITAGE PHARMA | ANDA 202644 | AB | Apr 25, 2013 | |
| NIFEDIPINE×3 | RISING | ANDA 201071 | — | Dec 03, 2010 | |
| NIFEDIPINE×3 | RISING | ANDA 090602 | — | Sep 13, 2010 | |
| NIFEDIPINE×3 | AUROBINDO PHARMA USA | ANDA 090649 | — | Jun 21, 2010 | |
| NIFEDIPINE×3 | PH HEALTH | ANDA 077899 | — | Dec 13, 2006 | |
| NIFEDIPINE×3 | OSMOTICA PHARM US | ANDA 077127 | AB2 | Nov 21, 2005 | |
| NIFEDIPINE | MARTEC USA LLC | ANDA 075414 | — | Mar 23, 2004 | |
| NIFEDIPINE | VALEANT PHARMS NORTH | ANDA 076070 | AB1 | Aug 16, 2002 | |
| AFEDITAB CR | WATSON LABS | ANDA 075659 | — | Oct 26, 2001 | |
| NIFEDIPINE×2 | VALEANT PHARMS NORTH | ANDA 075289 | AB2 | Feb 06, 2001 | |
| NIFEDIPINE×2 | VALEANT PHARMS NORTH | ANDA 075269 | AB1 | Dec 04, 2000 | |
| AFEDITAB CR | WATSON LABS TEVA | ANDA 075128 | — | Mar 10, 2000 | |
| NIFEDIPINE | PHARMOBEDIENT | ANDA 075108 | — | Dec 17, 1999 | |
| NIFEDIPINE | ACELLA | ANDA 072781 | AB | Jul 30, 1993 | |
| NIFEDIPINE | VELZEN PHARMA PVT | ANDA 074045 | AB | Apr 30, 1992 | |
| NIFEDIPINE | TEVA | ANDA 072651 | — | Feb 19, 1992 | |
| NIFEDIPINE | VELZEN PHARMA PVT | ANDA 073250 | AB | Oct 08, 1991 | |
| NIFEDIPINE | CHASE LABS NJ | ANDA 073421 | — | Jun 19, 1991 | |
| NIFEDIPINE | ACTAVIS ELIZABETH | ANDA 072579 | AB | Jan 08, 1991 | |
| NIFEDIPINE | ACTAVIS ELIZABETH | ANDA 072556 | — | Sep 20, 1990 | |
| NIFEDIPINE | CHASE LABS NJ | ANDA 072409 | — | Jul 04, 1990 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Nifedipine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
