FDA Orange Book · active-ingredient family
Sertraline hydrochloride
Sertraline hydrochloride is approved as 3 brand and 36 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SERTRALINE HYDROCHLORIDE · NDA 215133
3
Brand (NDA)
36
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule, concentrate, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDERLD×2 | ALMATICA | NDA 215133 | AB | Oct 04, 2021 | |
| ZOLOFTRLD | VIATRIS | NDA 020990 | AA | Dec 07, 1999 | |
| ZOLOFTRLD×5 | VIATRIS | NDA 019839 | AB | Mar 06, 1996 |
Generic (ANDA) products (36)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE×2 | ZYDUS LIFESCIENCES | ANDA 220275 | AB | Jan 29, 2026 | |
| SERTRALINE HYDROCHLORIDE×2 | AMNEAL | ANDA 219655 | AB | Jan 28, 2026 | |
| SERTRALINE HYDROCHLORIDE×2 | APPCO | ANDA 218712 | AB | Jan 20, 2026 | |
| SERTRALINE HYDROCHLORIDE×2 | NOVITIUM PHARMA | ANDA 219714 | AB | Jan 20, 2026 | |
| SERTRALINE HYDROCHLORIDE×2 | UMEDICA | ANDA 218342 | AB | Jan 20, 2026 | |
| SERTRALINE HYDROCHLORIDE×2 | ZENARA | ANDA 218853 | AB | Jul 16, 2025 | |
| SERTRALINE HYDROCHLORIDE×3 | ASCENT PHARMS INC | ANDA 214790 | AB | May 03, 2021 | |
| SERTRALINE HYDROCHLORIDE×3 | ACCORD HLTHCARE | ANDA 202825 | AB | Nov 07, 2014 | |
| SERTRALINE HYDROCHLORIDE×3 | OXFORD PHARMS | ANDA 078175 | AB | Jul 21, 2010 | |
| SERTRALINE HYDROCHLORIDE×3 | HIKMA PHARMS | ANDA 077864 | — | Aug 10, 2009 | |
| SERTRALINE HYDROCHLORIDE×3 | REYOUNG | ANDA 078677 | AB | Mar 04, 2009 | |
| SERTRALINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 078861 | AA | Oct 31, 2008 | |
| SERTRALINE HYDROCHLORIDE×3 | QUAGEN | ANDA 078626 | — | Jan 31, 2008 | |
| SERTRALINE HYDROCHLORIDE×3 | GRANULES | ANDA 078403 | AB | Jan 08, 2008 | |
| SERTRALINE HYDROCHLORIDE×3 | SCIEGEN PHARMS | ANDA 076442 | AB | Apr 30, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | MYLAN PHARMS INC | ANDA 076540 | — | Mar 20, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | APPCO | ANDA 077713 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | AUROBINDO PHARMA | ANDA 077206 | AB | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | CHARTWELL MOLECULAR | ANDA 077162 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | HERITAGE PHARMA AVET | ANDA 077299 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | HERITAGE PHARMA AVET | ANDA 077345 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | HERITAGE PHARMA AVET | ANDA 077663 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | INVAGEN PHARMS | ANDA 077397 | AB | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | LUPIN | ANDA 077670 | AB | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | PHARMACO | ANDA 076882 | AB | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | PHARMOBEDIENT | ANDA 076671 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | STRIDES PHARMA | ANDA 076881 | AB | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | SUN PHARM INDS (IN) | ANDA 078108 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×5 | SUN PHARM INDS LTD | ANDA 077977 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | TORRENT PHARMS | ANDA 077765 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | TP ANDA HOLDINGS | ANDA 077818 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | ZYDUS | ANDA 077106 | — | Feb 06, 2007 | |
| SERTRALINE HYDROCHLORIDE | RANBAXY LABS LTD | ANDA 078053 | — | Feb 05, 2007 | |
| SERTRALINE HYDROCHLORIDE×3 | HERITAGE | ANDA 076465 | AB | Aug 11, 2006 | |
| SERTRALINE HYDROCHLORIDE | STRIDES PHARMA | ANDA 076934 | AA | Jun 30, 2006 | |
| SERTRALINE HYDROCHLORIDE×3 | IVAX SUB TEVA PHARMS | ANDA 075719 | — | Jun 30, 2006 |
Marketing exclusivity (2)
- CGTFDA marketing exclusivity
Jan 18, 2026
5 mo ago
- CGTFDA marketing exclusivity
Jan 18, 2026
5 mo ago
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.
Sertraline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
