Orange Book product · Brand (NDA)
ZOLOFT
SERTRALINE HYDROCHLORIDE
At a glance
Mar 06, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 06, 1996
30 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
SERTRALINE HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019839
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021SERTRALINE HYDROCHLORIDEBrand (NDA)
NDA 215133 · ALMATICA
- 1999ZOLOFTBrand (NDA)
NDA 020990 · 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
- 2025SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218853 · ZENARA
- 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
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.
