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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204284

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NDA 204284 describes ZOLMITRIPTAN, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Glenmark Generics, Jubilant Generics, Macleods Pharms Ltd, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Appco Pharma Llc, Aurobindo Pharma Ltd, Invagen Pharms, Mylan Pharms Inc, Pld Acquisitions Llc, Sun Pharma Global, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from sixteen suppliers. Additional details are available on the ZOLMITRIPTAN profile page.

The generic ingredient in ZOLMITRIPTAN 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 204284
Applicant:Invagen Pharms
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204284
Suppliers and Packaging for NDA: 204284
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLMITRIPTAN zolmitriptan TABLET;ORAL 204284 ANDA Camber Pharmaceuticals Inc 31722-458 E 31722-458-06
ZOLMITRIPTAN zolmitriptan TABLET;ORAL 204284 ANDA Camber Pharmaceuticals Inc 31722-459 E 31722-459-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Apr 9, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 9, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
US Army

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