Orange Book product · Generic (ANDA)
SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE
At a glance
Jul 16, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2025
11 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Jan 18, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
SERTRALINE HYDROCHLORIDE
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 218853
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SERTRALINE HYDROCHLORIDE
- 2021SERTRALINE HYDROCHLORIDEBrand (NDA)
NDA 215133 · ALMATICA
- 1999ZOLOFTBrand (NDA)
NDA 020990 · VIATRIS
- 1996ZOLOFTBrand (NDA)
NDA 019839 · VIATRIS
- 2026SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220275 · ZYDUS LIFESCIENCES
- 2026SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219655 · AMNEAL
- 2026SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218712 · APPCO
- 2026SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219714 · NOVITIUM PHARMA
- 2026SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218342 · UMEDICA
- 2021SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214790 · ASCENT PHARMS INC
- 2014SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202825 · ACCORD HLTHCARE
- 2010SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078175 · OXFORD PHARMS
- 2009SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077864 · HIKMA PHARMS
Marketing exclusivity (1)
- 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.
