Orange Book product · Generic (ANDA)
SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE
At a glance
Mar 04, 2009
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 2009
17 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
SERTRALINE HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 078677
Product number
001
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
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NDA 020990 · VIATRIS
- 1996ZOLOFTBrand (NDA)
NDA 019839 · VIATRIS
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ANDA 219655 · AMNEAL
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ANDA 218712 · APPCO
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ANDA 219714 · NOVITIUM PHARMA
- 2026SERTRALINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218342 · UMEDICA
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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
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.
