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FDA ANDA · ANDA078108

SERTRALINE HYDROCHLORIDE

Sponsor: SUN PHARM INDS (IN)

APPLICATION
ANDA078108
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2007-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL

Approval history

2007-02-06OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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