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FDA ANDA · ANDA075719

SERTRALINE HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075719
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-30
LATEST ACTION
2008-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2008-08-28Labeling · Supplement 4AP
2008-01-09Labeling · Supplement 2AP
2008-01-09Labeling · Supplement 3AP
2008-01-09Labeling · Supplement 1AP
2006-06-30Original — Other Important Information from FDA ↗AP
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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