FDA Orange Book · active-ingredient family
Paroxetine hydrochloride
Paroxetine hydrochloride is approved as 4 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PAXIL CR · NDA 020936
4
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, suspension, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PAXIL CRRLD×3 | APOTEX | NDA 020936 | AB | Feb 16, 1999 | |
| PAXILRLD×4 | APOTEX | NDA 020885 | — | Oct 09, 1998 | |
| PAXILRLD | APOTEX | NDA 020710 | — | Jun 25, 1997 | |
| PAXILRLD×5 | APOTEX | NDA 020031 | AB | Dec 29, 1992 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE×3 | ALEMBIC | ANDA 217280 | AB | Mar 26, 2026 | |
| PAROXETINE HYDROCHLORIDE | ANNORA PHARMA | ANDA 219954 | AB | Mar 05, 2026 | |
| PAROXETINE HYDROCHLORIDE×2 | PRINSTON INC | ANDA 209748 | AB | Jan 04, 2024 | |
| PAROXETINE HYDROCHLORIDE×4 | YILING | ANDA 211248 | AB | Nov 02, 2021 | |
| PAROXETINE HYDROCHLORIDE | NOVITIUM PHARMA | ANDA 215003 | AB | Sep 03, 2021 | |
| PAROXETINE HYDROCHLORIDE×3 | CADILA PHARMS LTD | ANDA 212645 | AB | Aug 27, 2021 | |
| PAROXETINE HYDROCHLORIDE×3 | EPIC PHARMA LLC | ANDA 213612 | — | Aug 11, 2021 | |
| PAROXETINE HYDROCHLORIDE×3 | CSPC OUYI | ANDA 213485 | AB | Feb 16, 2021 | |
| PAROXETINE HYDROCHLORIDE×3 | SCIECURE PHARMA INC | ANDA 209293 | AB | Jun 12, 2018 | |
| PAROXETINE HYDROCHLORIDE×3 | LUPIN | ANDA 204134 | AB | Jan 20, 2017 | |
| PAROXETINE HYDROCHLORIDE×3 | LANNETT CO INC | ANDA 204744 | AB | Jun 10, 2016 | |
| PAROXETINE HYDROCHLORIDE×4 | JUBILANT GENERICS | ANDA 205528 | — | Nov 27, 2015 | |
| PAROXETINE×4 | PRINSTON INC | ANDA 203854 | AB | Oct 31, 2014 | |
| PAROXETINE HYDROCHLORIDE | AUROBINDO PHARMA USA | ANDA 091427 | AB | Apr 14, 2011 | |
| PAROXETINE HYDROCHLORIDE×4 | OXFORD PHARMS | ANDA 076968 | AB | Jun 21, 2010 | |
| PAROXETINE HYDROCHLORIDE×4 | MYLAN | ANDA 078902 | AB | Mar 13, 2008 | |
| PAROXETINE HYDROCHLORIDE×4 | AUROBINDO PHARMA | ANDA 078406 | AB | Jul 25, 2007 | |
| PAROXETINE HYDROCHLORIDE×2 | AUROBINDO PHARMA USA | ANDA 077873 | AB | Jun 29, 2007 | |
| PAROXETINE HYDROCHLORIDE×4 | ROXANE | ANDA 078026 | — | Jun 29, 2007 | |
| PAROXETINE HYDROCHLORIDE×4 | SUN PHARM INDS INC | ANDA 078194 | — | Jun 29, 2007 | |
| PAROXETINE HYDROCHLORIDE×4 | TEVA PHARMS | ANDA 077082 | — | Jun 29, 2007 | |
| PAROXETINE HYDROCHLORIDE×4 | ZYDUS PHARMS USA | ANDA 077584 | AB | Mar 07, 2007 | |
| PAROXETINE HYDROCHLORIDE | APOTEX INC | ANDA 077395 | — | Dec 05, 2006 | |
| PAROXETINE HYDROCHLORIDE×4 | CHARTWELL RX | ANDA 076618 | AB | Aug 15, 2005 | |
| PAROXETINE HYDROCHLORIDE×4 | PHARMOBEDIENT | ANDA 075716 | — | Mar 08, 2004 | |
| PAROXETINE HYDROCHLORIDE×4 | UPSHER SMITH LABS | ANDA 075566 | — | Mar 08, 2004 | |
| PAROXETINE HYDROCHLORIDE×4 | APOTEX | ANDA 075356 | AB | Jul 30, 2003 |
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.
Paroxetine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
