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FDA ANDA · ANDA076465

SERTRALINE

Sponsor: HERITAGE

APPLICATION
ANDA076465
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-11
LATEST ACTION
2024-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-03-28Labeling · Supplement 23 · standardAP
2024-03-28Labeling · Supplement 20 · standardAP
2020-02-21Labeling · Supplement 19 · standardAP
2015-05-21Manufacturing (CMC) · Supplement 18 · unknownAP
2010-06-11Labeling · Supplement 9AP
2008-11-28Labeling · Supplement 13AP
2008-07-16Labeling · Supplement 12AP
2008-01-11Labeling · Supplement 6AP
2008-01-11Labeling · Supplement 7AP
2007-03-28Labeling · Supplement 2AP
2007-03-28Labeling · Supplement 3AP
2006-08-11Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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