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Details for New Drug Application (NDA): 204041

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NDA 204041 describes ZOLMITRIPTAN, which is a drug marketed by Aurobindo Pharma Ltd, Alembic Pharms Ltd, Macleods Pharms Ltd, Ajanta Pharma Ltd, Jubilant Generics, Glenmark Generics, Teva Pharms Usa, Apotex Inc, Sun Pharma Global, Invagen Pharms, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. It is available from fourteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

Summary for NDA: 204041

Ajanta Pharma Ltd
Therapeutic Class:Antimigraine Agents

Pharmacology for NDA: 204041

Suppliers and Packaging for NDA: 204041

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 204041 ANDA Ajanta Pharma Limited 27241-021 27241-021-68 1 BLISTER PACK in 1 CARTON (27241-021-68) > 6 TABLET in 1 BLISTER PACK
TABLET;ORAL 204041 ANDA Ajanta Pharma Limited 27241-022 27241-022-38 1 BLISTER PACK in 1 CARTON (27241-022-38) > 3 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:May 20, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 20, 2016TE:ABRLD:No

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