Details for New Drug Application (NDA): 204041

NDA 204041 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, Aurobindo Pharma, Chartwell Rx, 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 twenty 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 204041

Tradename:	ZOLMITRIPTAN
Applicant:	Ajanta Pharma Ltd
Ingredient:	zolmitriptan
Patents:	0

Pharmacology for NDA: 204041

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 204041

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	204041	ANDA	Ajanta Pharma USA Inc.	27241-021	27241-021-68	1 BLISTER PACK in 1 CARTON (27241-021-68) / 6 TABLET in 1 BLISTER PACK
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	204041	ANDA	Ajanta Pharma USA Inc.	27241-022	27241-022-38	1 BLISTER PACK in 1 CARTON (27241-022-38) / 3 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	May 20, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 20, 2016	TE:	AB	RLD:	No

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