FDA Orange Book · active-ingredient family
Naproxen
Naproxen is approved as 3 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EC-NAPROSYN · NDA 020067
3
Brand (NDA)
37
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EC-NAPROSYNRLD×2 | ATNAHS PHARMA US | NDA 020067 | AB | Oct 14, 1994 | |
| NAPROSYNRLD | ATNAHS PHARMA US | NDA 018965 | AB | Mar 23, 1987 | |
| NAPROSYNRLD×3 | ATNAHS PHARMA US | NDA 017581 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (37)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAPROXEN | AUROBINDO PHARMA | ANDA 216504 | — | Oct 03, 2025 | |
| NAPROXEN×2 | NOVITIUM PHARMA | ANDA 218497 | AB | Jun 12, 2024 | |
| NAPROXEN×2 | TP ANDA HOLDINGS | ANDA 216908 | AB | May 31, 2023 | |
| NAPROXEN | HETERO LABS LTD III | ANDA 215776 | AB | Jun 07, 2022 | |
| NAPROXEN | NOVITIUM PHARMA | ANDA 211910 | AB | Mar 10, 2021 | |
| NAPROXEN | AMNEAL | ANDA 212705 | AB | Jul 31, 2020 | |
| NAPROXEN×3 | SCIEGEN PHARMS | ANDA 212517 | AB | Feb 21, 2020 | |
| NAPROXEN×3 | AUROBINDO PHARMA | ANDA 200429 | AB | Nov 08, 2011 | |
| NAPROXEN×2 | NUVO PHARMS INC | ANDA 091432 | AB | Sep 19, 2011 | |
| NAPROXEN×3 | INVAGEN PHARMS | ANDA 091305 | — | Aug 24, 2011 | |
| NAPROXEN×3 | ADAPTIS | ANDA 091416 | AB | Feb 14, 2011 | |
| NAPROXEN×3 | ZYDUS PHARMS USA | ANDA 078620 | AB | Jun 07, 2007 | |
| NAPROXEN×3 | GLENMARK PHARMS LTD | ANDA 078250 | AB | Mar 28, 2007 | |
| NAPROXEN×3 | L PERRIGO CO | ANDA 077339 | — | Apr 27, 2005 | |
| NAPROXEN×3 | HIKMA INTL PHARMS | ANDA 076494 | — | Jan 14, 2004 | |
| NAPROXEN×3 | AMNEAL PHARMS NY | ANDA 075927 | AB | Dec 18, 2001 | |
| NAPROXEN×2 | AUROBINDO PHARMA USA | ANDA 075390 | AB | Apr 19, 2001 | |
| NAPROXEN×2 | PLIVA | ANDA 075337 | — | May 26, 1999 | |
| NAPROXEN×2 | TEVA | ANDA 075227 | AB | Jun 30, 1998 | |
| NAPROXEN×2 | ACTAVIS ELIZABETH | ANDA 074936 | — | Feb 24, 1998 | |
| NAPROXEN×2 | FOSUN PHARMA | ANDA 075061 | — | Feb 18, 1998 | |
| NAPROXEN×3 | PLIVA | ANDA 074182 | — | Jun 27, 1996 | |
| NAPROXEN×3 | TEVA | ANDA 074216 | — | Apr 11, 1996 | |
| NAPROXEN×3 | WATSON LABS | ANDA 074457 | — | May 31, 1995 | |
| NAPROXEN×3 | CHARTWELL MOLECULES | ANDA 074410 | — | Apr 28, 1995 | |
| NAPROXEN×3 | IVAX SUB TEVA PHARMS | ANDA 074111 | — | Feb 28, 1995 | |
| NAPROXEN×3 | WATSON LABS TEVA | ANDA 074163 | — | Feb 10, 1995 | |
| NAPROXEN | HIKMA | ANDA 074190 | AB | Mar 30, 1994 | |
| NAPROXEN×3 | ROXANE | ANDA 074211 | — | Feb 28, 1994 | |
| NAPROXEN×3 | DAVA PHARMS INC | ANDA 074105 | — | Dec 21, 1993 | |
| NAPROXEN×3 | GRANULES | ANDA 074140 | AB | Dec 21, 1993 | |
| NAPROXEN×3 | PHARMOBEDIENT | ANDA 074121 | — | Dec 21, 1993 | |
| NAPROXEN×3 | PUREPAC PHARM | ANDA 074263 | — | Dec 21, 1993 | |
| NAPROXEN×3 | TEVA | ANDA 074129 | — | Dec 21, 1993 | |
| NAPROXEN×3 | TEVA | ANDA 074201 | AB | Dec 21, 1993 | |
| NAPROXEN×3 | TEVA PHARMS | ANDA 074207 | — | Dec 21, 1993 | |
| NAPROXEN×3 | HAMILTON PHARMS | ANDA 074110 | — | Oct 30, 1992 |
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.
Naproxen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
