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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202560


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NDA 202560 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, Appco, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Sun Pharma Global, and Zydus Pharms, and is included in twenty-three NDAs. It is available from nineteen 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-one suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.
Summary for 202560
Tradename:ZOLMITRIPTAN
Applicant:Glenmark Pharms Ltd
Ingredient:zolmitriptan
Patents:0
Pharmacology for NDA: 202560
Suppliers and Packaging for NDA: 202560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 202560 ANDA Glenmark Pharmaceuticals Inc., USA 68462-499 68462-499-76 1 BLISTER PACK in 1 CARTON (68462-499-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-499-40)
ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 202560 ANDA Glenmark Pharmaceuticals Inc., USA 68462-500 68462-500-33 1 BLISTER PACK in 1 CARTON (68462-500-33) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-500-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG
Approval Date:May 14, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:May 14, 2013TE:ABRLD:No

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