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FDA ANDA · ANDA078403

SERTRALINE HYDROCHLORIDE

Sponsor: GRANULES

APPLICATION
ANDA078403
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-08
LATEST ACTION
2023-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-09-22Labeling · Supplement 10 · standardAP
2023-03-31Labeling · Supplement 7 · standardAP
2023-03-31Labeling · Supplement 6 · standardAP
2010-04-21Labeling · Supplement 4AP
2009-09-28Labeling · Supplement 3AP
2009-04-21Labeling · Supplement 2AP
2008-01-08Original — Patient Information Sheet ↗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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