Details for New Drug Application (NDA): 215651

NDA 215651 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-eight suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for 215651

Tradename:	SUMATRIPTAN SUCCINATE
Applicant:	Onesource Specialty
Ingredient:	sumatriptan succinate
Patents:	0

Pharmacology for NDA: 215651

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 215651

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	215651	ANDA	ONESOURCE SPECIALTY PHARMA LIMITED	83270-005	83270-005-01	1 BLISTER PACK in 1 CARTON (83270-005-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE

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:	Nov 21, 2024	TE:	AP	RLD:	No

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