← FDA DRUG APPROVALS

FDA ANDA · ANDA078626

SERTRALINE HYDROCHLORIDE

Sponsor: QUAGEN

APPLICATION
ANDA078626
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-31
LATEST ACTION
2024-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2024-01-18Labeling · Supplement 18 · standardAP
2023-08-15Labeling · Supplement 17 · standardAP
2020-02-21Labeling · Supplement 15 · standardAP
2020-02-21Labeling · Supplement 13 · standardAP
2020-02-21Labeling · Supplement 14 · standardAP
2016-01-05Labeling · Supplement 9 · standardAP
2014-07-29Manufacturing (CMC) · Supplement 2AP
2014-06-02Labeling · Supplement 5 · standardAP
2012-04-26Labeling · Supplement 3AP
2009-08-31Labeling · Supplement 1AP
2008-01-31Original — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →