Last Updated: November 13, 2026

Details for New Drug Application (NDA): 078319

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NDA 078319 describes SUMATRIPTAN SUCCINATE (AUTOINJECTOR), which is a drug marketed by Alembic, Antares Pharma Inc, Dr Reddys, Onesource Specialty, and Sun Pharm, and is included in five NDAs. It is available from ten suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE (AUTOINJECTOR) profile page.

The generic ingredient in SUMATRIPTAN SUCCINATE (AUTOINJECTOR) is sumatriptan succinate. There is one drug master file entry for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for 078319

Tradename:	SUMATRIPTAN SUCCINATE (AUTOINJECTOR)
Applicant:	Antares Pharma Inc
Ingredient:	sumatriptan succinate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date:	Dec 10, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:	Dec 10, 2015	TE:		RLD:	No

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