FDA approval · Drugs@FDA

IMITREX STATDOSE (AUTOINJECTOR)sumatriptan succinate

NDA020080 · December 28, 1992

FDA approved the original new drug application for IMITREX STATDOSE (AUTOINJECTOR) on December 28, 1992. Today GLAXOSMITHKLINE holds the application (Drugs@FDA). FDA classed the original submission Type 1 - New Molecular Entity. FDA marks 1 of the application’s 3 products discontinued and the other 2 still marketed. FDA has approved 2 efficacy supplements on the application since, the most recent on February 1, 2006.

Application: NDA020080
Sponsor: GLAXOSMITHKLINEOpen the company page for GSK plc (GSK), the listed company we match this holder to.
Original approval: December 28, 1992
Review: priority review
Submission class: Type 1 - New Molecular Entity
Active ingredient: sumatriptan succinate

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Products under this application

Ingredient and strength	Form	Route	Marketing status
sumatriptan succinate EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE	SUBCUTANEOUS	Prescription
sumatriptan succinate EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE	SUBCUTANEOUS	Prescription
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succinate EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	SUBCUTANEOUS	Discontinued

What “discontinued” means in FDA’s record

Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.

Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

Approved	Supplement	Review
May 22, 1996	S-4	—
February 1, 2006	S-36	—

FDA records other approved supplements on this application, by the class code it assigns them: Labeling 20 · Manufacturing (CMC) 8. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-26). Every field on this page comes from that record.

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