Details for New Drug Application (NDA): 076572

NDA 076572 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience Speclts, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty 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-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for 076572

Tradename:	SUMATRIPTAN SUCCINATE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	sumatriptan succinate
Patents:	0

Pharmacology for NDA: 076572

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 076572

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076572	ANDA	Proficient Rx LP	63187-323	63187-323-09	1 BLISTER PACK in 1 CARTON (63187-323-09) / 9 TABLET in 1 BLISTER PACK
SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076572	ANDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	63304-099	63304-099-13	120 TABLET in 1 BOTTLE (63304-099-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Feb 9, 2009	TE:		RLD:	No

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