Details for New Drug Application (NDA): 201779

NDA 201779 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, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Somerset Theraps 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 201779

Tradename:	ZOLMITRIPTAN
Applicant:	Glenmark Pharms Ltd
Ingredient:	zolmitriptan
Patents:	0

Pharmacology for NDA: 201779

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 201779

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	201779	ANDA	BluePoint Laboratories	68001-249	68001-249-01	1 BLISTER PACK in 1 CARTON (68001-249-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK (68001-249-19)
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	201779	ANDA	BluePoint Laboratories	68001-250	68001-250-01	1 BLISTER PACK in 1 CARTON (68001-250-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (68001-250-18)

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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