Details for New Drug Application (NDA): 207867

NDA 207867 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 207867

Tradename:	ZOLMITRIPTAN
Applicant:	Pld Acquisitions Llc
Ingredient:	zolmitriptan
Patents:	0

Pharmacology for NDA: 207867

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 207867

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	207867	ANDA	Amneal Pharmaceuticals LLC	60846-130	60846-130-30	1 BLISTER PACK in 1 CARTON (60846-130-30) / 6 TABLET, FILM COATED in 1 BLISTER PACK
ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	207867	ANDA	Amneal Pharmaceuticals LLC	60846-133	60846-133-60	1 BLISTER PACK in 1 CARTON (60846-133-60) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Feb 27, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 27, 2017	TE:	AB	RLD:	No

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