APPLICATION
ANDA090314
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-10
LATEST ACTION
2020-07-20
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)Prescription
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
SUMATRIPTAN SUCCINATEDiscontinued
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
Approval history
2020-07-20Labeling · Supplement 6 · standardAP
2020-07-20Labeling · Supplement 9 · standardAP
2015-11-10Labeling · Supplement 4 · standardAP
2015-11-10Manufacturing (CMC) · Supplement 2 · unknownAP
2010-06-10OriginalAP
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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