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FDA ANDA · ANDA090358

SUMATRIPTAN SUCCINATE

Sponsor: SUN PHARM

APPLICATION
ANDA090358
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-21
LATEST ACTION
2023-06-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2023-06-06Labeling · Supplement 29 · standardAP
2019-10-29Manufacturing (CMC) · Supplement 19 · unknownAP
2019-05-22Labeling · Supplement 15 · standardAP
2016-02-09Labeling · Supplement 9 · standardAP
2016-02-09Labeling · Supplement 3 · standardAP
2016-02-09Labeling · Supplement 11 · standardAP
2014-03-14Labeling · Supplement 1AP
2011-06-21Original — Review ↗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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