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Generated: November 16, 2018

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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 021231
Tradename:ZOMIG-ZMT
Applicant:Astrazeneca
Ingredient:zolmitriptan
Patents:0
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 Impax Generics 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 Impax Generics 0115-0692 0115-0692-50 1 BLISTER PACK in 1 CARTON (0115-0692-50) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG
Approval Date:Feb 13, 2001TE:ABRLD:Yes

Profile for product number 002

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

Expired US Patents for NDA 021231

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-001 Feb 13, 2001 ➤ Sign Up ➤ Sign Up
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-002 Sep 17, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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