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FDA ANDA · ANDA076934

SERTRALINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA

APPLICATION
ANDA076934
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-30
LATEST ACTION
2019-04-05
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription

Products

SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML · CONCENTRATE · ORAL

Approval history

2019-04-05Labeling · Supplement 7 · standardAP
2015-11-19Labeling · Supplement 6 · standardAP
2008-07-16Labeling · Supplement 5AP
2008-01-09Labeling · Supplement 4AP
2008-01-09Labeling · Supplement 3AP
2006-06-30Original — 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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