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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 208967

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NDA 208967 describes SUMATRIPTAN, which is a drug marketed by Adaptis, Cipla, 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 Speclts, 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 208967

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

Pharmacology for NDA: 208967

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

Medical Subject Heading (MeSH) Categories for 208967

Serotonin 5-HT1 Receptor Agonists
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 208967

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMATRIPTAN	sumatriptan	SPRAY;NASAL	208967	ANDA	Florida Pharmaceutical Products, LLC.	71921-170	71921-170-61	6 CONTAINER in 1 BOX (71921-170-61) / 1 SPRAY in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	20MG/SPRAY
Approval Date:	Feb 17, 2021	TE:	AB	RLD:	No

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