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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 020768


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NDA 020768 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 020768
Tradename:ZOMIG
Applicant:Ipr
Ingredient:zolmitriptan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020768
Suppliers and Packaging for NDA: 020768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOMIG zolmitriptan TABLET;ORAL 020768 NDA Amneal Pharmaceuticals 64896-671 64896-671-49 1 BLISTER PACK in 1 CARTON (64896-671-49) / 2 TABLET in 1 BLISTER PACK
ZOMIG zolmitriptan TABLET;ORAL 020768 NDA Amneal Pharmaceuticals 64896-671 64896-671-51 1 BLISTER PACK in 1 CARTON (64896-671-51) / 6 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 25, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Nov 25, 1997TE:RLD:Yes

Expired US Patents for NDA 020768

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-001 Nov 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-001 Nov 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-002 Nov 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-002 Nov 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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