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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203186

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NDA 203186 describes ZOLMITRIPTAN, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Glenmark Generics, Jubilant Generics, Macleods Pharms Ltd, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Appco Pharma Llc, Aurobindo Pharma Ltd, Invagen Pharms, Mylan Pharms Inc, Pld Acquisitions Llc, Sun Pharma Global, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from seventeen suppliers. Additional details are available on the ZOLMITRIPTAN profile page.

The generic ingredient in ZOLMITRIPTAN is zolmitriptan. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

Summary for 203186

Tradename:	ZOLMITRIPTAN
Applicant:	Mylan Pharms Inc
Ingredient:	zolmitriptan
Patents:	0
Therapeutic Class:	Antimigraine Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 203186

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

Suppliers and Packaging for NDA: 203186

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	203186	ANDA	Mylan Pharmaceuticals Inc.	0378-4260	N	0378-4260-56

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	May 14, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 14, 2013	TE:	AB	RLD:	No

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