← FDA DRUG APPROVALS

FDA NDA · NDA020080

IMITREX

sumatriptan

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020080
TYPE
NDA
ORIGINAL APPROVAL
1992-12-28
LATEST ACTION
2025-12-09
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

IMITREX STATDOSE · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
IMITREX STATDOSE · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
IMITREX · ReferenceDiscontinued
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · SUBCUTANEOUS

Approval history

2025-12-09Labeling · Supplement 55 · standard — Letter ↗AP
2021-12-20Labeling · Supplement 54 · standard — Letter ↗AP
2021-03-23Labeling · Supplement 53 · standard — Letter ↗AP
2018-07-17Labeling · Supplement 52 · standard — Label ↗AP
2017-12-14Labeling · Supplement 50 · standard — Label ↗AP
2015-11-19Labeling · Supplement 49 · standard — Letter ↗AP
2015-06-11Labeling · Supplement 48 · standard — Label ↗AP
2012-10-02Labeling · Supplement 40 · standard — Label ↗AP
2012-10-02Labeling · Supplement 39 · standard — Letter ↗AP
2012-10-02Labeling · Supplement 45 · unknown — Letter ↗AP
2012-10-02Labeling · Supplement 41 · standard — Label ↗AP
2010-07-21Labeling · Supplement 38 · standard — Letter ↗AP
2006-02-01Efficacy · Supplement 36 · unknown — Label ↗AP
2003-07-28Labeling · Supplement 30 · standard — Review ↗AP
2003-01-03Labeling · Supplement 29 · standard — Letter ↗AP
2001-02-02Labeling · Supplement 21 · standardAP
2001-02-02Labeling · Supplement 26 · standardAP
2001-02-02Labeling · Supplement 24 · standardAP
2001-02-02Labeling · Supplement 27 · standardAP
2001-02-02Labeling · Supplement 25 · standardAP
1997-12-16Manufacturing (CMC) · Supplement 22 · priorityAP
1997-11-26Manufacturing (CMC) · Supplement 23 · priorityAP
1996-12-23Manufacturing (CMC) · Supplement 5 · priority — Review ↗AP
1996-05-22Efficacy · Supplement 4 · unknownAP
1996-03-28Manufacturing (CMC) · Supplement 20 · priorityAP
1995-11-29Manufacturing (CMC) · Supplement 18 · priorityAP
1995-10-05Manufacturing (CMC) · Supplement 17 · priorityAP
1995-06-07Manufacturing (CMC) · Supplement 14 · priorityAP
1994-08-17Labeling · Supplement 3 · standardAP
1993-09-30Manufacturing (CMC) · Supplement 2 · priorityAP
1992-12-28Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →