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Details for New Drug Application (NDA): 021231

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NDA 021231 describes ZOMIG-ZMT, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from two suppliers. Additional details are available on the ZOMIG-ZMT profile page.

The generic ingredient in ZOMIG-ZMT 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: 021231

Tradename:
ZOMIG-ZMT
Applicant:
Astrazeneca
Ingredient:
zolmitriptan
Patents:0
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021231

Suppliers and Packaging for NDA: 021231

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL 021231 NDA Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-0691 0115-0691-51 1 BLISTER PACK in 1 CARTON (0115-0691-51) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL 021231 NDA Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-0692 0115-0692-50 1 BLISTER PACK in 1 CARTON (0115-0692-50) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG
Approval Date:Feb 13, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Sep 17, 2001TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 021231

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL021231-001Feb 13, 20015,466,699*PED► subscribe
Astrazeneca
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL021231-002Sep 17, 20015,466,699*PED► subscribe
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