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Last Updated: March 28, 2024

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 one supplier. 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 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021450
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 64896-681 64896-681-30 1 BOTTLE, SPRAY in 1 CARTON (64896-681-30) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY
ZOMIG zolmitriptan SPRAY;NASAL 021450 NDA Amneal Pharmaceuticals 64896-681 64896-681-51 6 BOTTLE, SPRAY in 1 CARTON (64896-681-51) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength2.5MG/SPRAY
Approval Date:Sep 16, 2013TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Sep 30, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021450

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

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