Details for New Drug Application (NDA): 090495

NDA 090495 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 090495

Tradename:	SUMATRIPTAN SUCCINATE
Applicant:	Dr Reddys
Ingredient:	sumatriptan succinate
Patents:	0

Pharmacology for NDA: 090495

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 090495

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090495	ANDA	NorthStar Rx LLC	16714-040	16714-040-02	2 SYRINGE in 1 CARTON (16714-040-02) / .5 mL in 1 SYRINGE (16714-040-01)
SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090495	ANDA	Dr. Reddy?s Laboratories Inc.,	43598-768	43598-768-23	2 SYRINGE in 1 CARTON (43598-768-23) / .5 mL in 1 SYRINGE (43598-768-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:	Jan 29, 2014	TE:	AB	RLD:	No

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