APPLICATION
ANDA204841
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-19
LATEST ACTION
2018-06-26
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription
Products
SUMATRIPTANPrescription
SUMATRIPTAN 20MG/SPRAY · SPRAY · NASAL
SUMATRIPTANPrescription
SUMATRIPTAN 5MG/SPRAY · SPRAY · NASAL
Approval history
2018-06-26Manufacturing (CMC) · Supplement 8 · unknownAP
2018-06-26Labeling · Supplement 11 · standardAP
2016-02-19UNKNOWN · 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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