Details for New Drug Application (NDA): 202758

NDA 202758 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 202758

Tradename:	SUMATRIPTAN SUCCINATE
Applicant:	Eugia Pharma
Ingredient:	sumatriptan succinate
Patents:	0

Pharmacology for NDA: 202758

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 202758

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	202758	ANDA	AuroMedics Pharma LLC	55150-173	55150-173-05	5 VIAL, SINGLE-DOSE in 1 CARTON (55150-173-05) / .5 mL in 1 VIAL, SINGLE-DOSE
SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	202758	ANDA	AuroMedics Pharma LLC	55150-173	55150-173-01	5 VIAL, SINGLE-DOSE in 1 CARTON (55150-173-01) / .5 mL in 1 VIAL, SINGLE-DOSE

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:	Apr 23, 2013	TE:	AP	RLD:	No

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