Details for New Drug Application (NDA): 204232

NDA 204232 describes ZOLMITRIPTAN, which is a drug marketed by Padagis Israel, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Ani Pharms, Appco, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Sun Pharma Global, and Zydus Pharms, and is included in twenty-three NDAs. It is available from nineteen 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 204232

Tradename:	ZOLMITRIPTAN
Applicant:	Alembic
Ingredient:	zolmitriptan
Patents:	0

Pharmacology for NDA: 204232

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 204232

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	204232	ANDA	Alembic Pharmaceuticals Limited	46708-462	46708-462-06	6 TABLET, FILM COATED in 1 CARTON (46708-462-06)
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	204232	ANDA	Alembic Pharmaceuticals Limited	46708-463	46708-463-03	3 TABLET, FILM COATED in 1 CARTON (46708-463-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 30, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 30, 2015	TE:	AB	RLD:	No

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