← FDA DRUG APPROVALS

FDA NDA · NDA020132

IMITREX

sumatriptan

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020132
TYPE
NDA
ORIGINAL APPROVAL
1995-06-01
LATEST ACTION
2025-12-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

IMITREX · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 25MG BASE · TABLET · ORAL
IMITREX · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 50MG BASE · TABLET · ORAL
IMITREX · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 100MG BASE · TABLET · ORAL

Approval history

2025-12-09Labeling · Supplement 31 · standard — Letter ↗AP
2021-03-23Labeling · Supplement 30 · standard — Letter ↗AP
2017-12-14Labeling · Supplement 29 · standard — Label ↗AP
2013-11-25Labeling · Supplement 28 · standard — Label ↗AP
2012-03-01Labeling · Supplement 26 · unknown — Letter ↗AP
2012-03-01Labeling · Supplement 24 · standard — Letter ↗AP
2010-08-11Labeling · Supplement 22 · standard — Letter ↗AP
2010-08-11Labeling · Supplement 20 · standard — Label ↗AP
2010-08-11Labeling · Supplement 21 · standard — Letter ↗AP
2010-08-11Labeling · Supplement 13 · standard — Letter ↗AP
2004-06-17Labeling · Supplement 18 · standard — Letter ↗AP
2003-07-28Labeling · Supplement 14 · standard — Review ↗AP
2003-06-30Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
2001-06-25Labeling · Supplement 12 · standardAP
2001-06-25Manufacturing (CMC) · Supplement 11 · standardAP
2001-02-09Labeling · Supplement 7 · standardAP
2001-02-09Labeling · Supplement 10 · standardAP
2001-02-09Labeling · Supplement 8 · standardAP
1998-02-24Labeling · Supplement 6 · standardAP
1998-02-13Efficacy · Supplement 3 · standardAP
1997-12-16Manufacturing (CMC) · Supplement 5 · standardAP
1996-03-28Manufacturing (CMC) · Supplement 1 · standardAP
1995-06-01Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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