APPLICATION
ANDA214209
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-22
LATEST ACTION
2026-06-12
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription
Products
SUMATRIPTANPrescription
SUMATRIPTAN 20MG/SPRAY · SPRAY · NASAL
Approval history
2026-06-12Labeling · Supplement 5 · standardAP
2024-06-05Manufacturing (CMC) · Supplement 2 · unknownAP
2021-02-22UNKNOWN · Original · standardAP
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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