← FDA DRUG APPROVALS

FDA NDA · NDA020626

SUMATRIPTAN

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020626
TYPE
NDA
ORIGINAL APPROVAL
1997-08-26
LATEST ACTION
2025-12-09
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Discontinued, Prescription

Products

IMITREXDiscontinued
SUMATRIPTAN 10MG/SPRAY · SPRAY · NASAL
IMITREX · ReferencePrescription
SUMATRIPTAN 20MG/SPRAY · SPRAY · NASAL
IMITREX · ReferencePrescription
SUMATRIPTAN 5MG/SPRAY · SPRAY · NASAL

Approval history

2025-12-09Labeling · Supplement 29 · standard — Letter ↗AP
2017-12-14Labeling · Supplement 27 · standard — Label ↗AP
2016-03-25Manufacturing (CMC) · Supplement 26 · standardAP
2013-11-25Labeling · Supplement 25 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 18 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 22 · unknown — Label ↗AP
2010-07-21Labeling · Supplement 15 · standard — Label ↗AP
2010-07-21Labeling · Supplement 13 · standard — Letter ↗AP
2010-07-21Labeling · Supplement 16 · standard — Label ↗AP
2004-10-13Efficacy · Supplement 4 · standard — Pediatric Medical Review ↗AP
2003-07-28Labeling · Supplement 7 · standard — Review ↗AP
2002-05-10Labeling · Supplement 6 · standard — Letter ↗AP
2000-12-11Labeling · Supplement 3 · standardAP
2000-06-01Labeling · Supplement 2 · standard — Review ↗AP
2000-06-01Labeling · Supplement 1 · standard — Review ↗AP
1997-08-26Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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