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Details for New Drug Application (NDA): 203476

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NDA 203476 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: 203476

Tradename:
ZOLMITRIPTAN
Applicant:
Sun Pharma Global
Ingredient:
zolmitriptan
Patents:0
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203476

Suppliers and Packaging for NDA: 203476

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLMITRIPTAN
zolmitriptan
TABLET;ORAL 203476 ANDA Sun Pharma Global FZE 47335-978 47335-978-13 500 TABLET, FILM COATED in 1 BOTTLE (47335-978-13)
ZOLMITRIPTAN
zolmitriptan
TABLET;ORAL 203476 ANDA Sun Pharma Global FZE 47335-978 47335-978-63 1 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-978-63) > 6 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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


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