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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214209

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NDA 214209 describes SUMATRIPTAN, which is a drug marketed by Cipla, Florida, Lannett Co Inc, Padagis Israel, Aurobindo Pharma Ltd, Rising, Sun Pharm, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience, 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 forty-one NDAs. It is available from six suppliers. Additional details are available on the SUMATRIPTAN profile page.

The generic ingredient in SUMATRIPTAN 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 214209

Tradename:	SUMATRIPTAN
Applicant:	Cipla
Ingredient:	sumatriptan
Patents:	0

Pharmacology for NDA: 214209

Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Medical Subject Heading (MeSH) Categories for 214209

Serotonin 5-HT1 Receptor Agonists
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 214209

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMATRIPTAN	sumatriptan	SPRAY;NASAL	214209	ANDA	Cipla USA Inc.	69097-644	69097-644-48	6 CONTAINER in 1 BOX (69097-644-48) / 1 SPRAY in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	20MG/SPRAY
Approval Date:	Feb 22, 2021	TE:	AB	RLD:	No

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