Details for New Drug Application (NDA): 021450

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NDA 021450 describes ZOMIG, which is a drug marketed by Amneal, IPR, and Astrazeneca, and is included in three NDAs. It is available from three suppliers. Additional details are available on the ZOMIG profile page.

The generic ingredient in ZOMIG 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 021450

Tradename:	ZOMIG
Applicant:	Amneal
Ingredient:	zolmitriptan
Patents:	0

Pharmacology for NDA: 021450

Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 021450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOMIG	zolmitriptan	SPRAY;NASAL	021450	NDA	Amneal Pharmaceuticals LLC	64896-083	64896-083-12	6 BOTTLE, SPRAY in 1 CARTON (64896-083-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY
ZOMIG	zolmitriptan	SPRAY;NASAL	021450	NDA	Amneal Pharmaceuticals LLC	64896-084	64896-084-12	6 BOTTLE, SPRAY in 1 CARTON (64896-084-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	2.5MG/SPRAY
Approval Date:	Sep 16, 2013	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	5MG/SPRAY
Approval Date:	Sep 30, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021450

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	⤷ Sign Up	⤷ Sign Up
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	⤷ Sign Up	⤷ Sign Up
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	⤷ Sign Up	⤷ Sign Up
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	⤷ Sign Up	⤷ Sign Up
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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