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Details for New Drug Application (NDA): 020768

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NDA 020768 describes ZOMIG, which is a drug marketed by Astrazeneca and IPR and is included in three NDAs. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Nineteen suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

Summary for NDA: 020768

Tradename:
ZOMIG
Applicant:
Ipr
Ingredient:
zolmitriptan
Patents:0
Therapeutic Class:Antimigraine Agents
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 Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-0671 0115-0671-51 1 BLISTER PACK in 1 CARTON (0115-0671-51) > 6 TABLET in 1 BLISTER PACK
ZOMIG
zolmitriptan
TABLET;ORAL 020768 NDA Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-0672 0115-0672-50 1 BLISTER PACK in 1 CARTON (0115-0672-50) > 3 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 25, 1997TE:ABRLD:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020768

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr
ZOMIG
zolmitriptan
TABLET;ORAL020768-001Nov 25, 19975,466,699*PED► subscribe
Ipr
ZOMIG
zolmitriptan
TABLET;ORAL020768-002Nov 25, 19975,863,935*PED► subscribe
Ipr
ZOMIG
zolmitriptan
TABLET;ORAL020768-002Nov 25, 19975,466,699*PED► subscribe
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