Details for New Drug Application (NDA): 212469

NDA 212469 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 212469

Tradename:	ZOLMITRIPTAN
Applicant:	Padagis Israel
Ingredient:	zolmitriptan
Patents:	0

Pharmacology for NDA: 212469

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 212469

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLMITRIPTAN	zolmitriptan	SPRAY;NASAL	212469	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-711	45802-711-91	6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)
ZOLMITRIPTAN	zolmitriptan	SPRAY;NASAL	212469	ANDA	Bryant Ranch Prepack	63629-9575	63629-9575-1	6 BOTTLE, SPRAY in 1 CARTON (63629-9575-1) / 1 SPRAY in 1 BOTTLE, SPRAY (63629-9575-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	2.5MG/SPRAY
Approval Date:	Sep 30, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	5MG/SPRAY
Approval Date:	Sep 30, 2021	TE:	AB	RLD:	No

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