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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078318

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NDA 078318 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Alembic, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Onesource Specialty, Ph Health, Sandoz, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Wockhardt Bio Ag, Zydus, Aurobindo Pharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Ipca Labs Ltd, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Vkt Pharma, Watson Labs, and Zhejiang, and is included in thirty-eight NDAs. It is available from thirty-three suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE profile page.

The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for 078318

Tradename:	SUMATRIPTAN SUCCINATE
Applicant:	Teva Parenteral
Ingredient:	sumatriptan succinate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date:	Feb 6, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:	Feb 6, 2009	TE:		RLD:	No

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