APPLICATION
ANDA202758
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-23
LATEST ACTION
2025-07-25
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
2025-07-25Labeling · Supplement 10 · standardAP
2024-05-23Labeling · Supplement 8 · standardAP
2020-08-25Labeling · Supplement 5 · standardAP
2020-08-25Labeling · Supplement 6 · standardAP
2015-09-11Labeling · Supplement 3 · standardAP
2013-04-23UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.