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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 203476


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NDA 203476 describes ZOLMITRIPTAN, which is a drug marketed by Padagis Israel, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Ani Pharms, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Somerset Theraps Llc, Sun Pharma Global, and Zydus Pharms, and is included in twenty-three NDAs. It is available from twenty 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-two suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.
Summary for 203476
Tradename:ZOLMITRIPTAN
Applicant:Sun Pharma Global
Ingredient:zolmitriptan
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 13, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Nov 13, 2014TE:RLD:No

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