← FDA DRUG APPROVALS

FDA ANDA · ANDA076933

SUMATRIPTAN SUCCINATE

Sponsor: WATSON LABS

APPLICATION
ANDA076933
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-10
LATEST ACTION
2015-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 50MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 100MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 25MG BASE · TABLET · ORAL

Approval history

2015-07-02Labeling · Supplement 8 · standardAP
2015-07-02Labeling · Supplement 3 · standardAP
2012-03-13Labeling · Supplement 1AP
2009-08-10Original — Letter ↗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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