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Details for New Drug Application (NDA): 203503

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NDA 203503 describes VORICONAZOLE, which is a drug marketed by Glenmark Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Mylan Pharms Inc, Zydus Pharms Usa Inc, Versapharm Inc, Prinston Inc, Teva Pharms, Sandoz Inc, Appco Pharma Llc, Novel Labs Inc, Ajanta Pharma Ltd, and Alvogen Inc, and is included in sixteen NDAs. It is available from twenty-one suppliers. Additional details are available on the VORICONAZOLE profile page.

The generic ingredient in VORICONAZOLE is voriconazole. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the voriconazole profile page.

Summary for NDA: 203503

Glenmark Pharms Ltd
Therapeutic Class:Antifungals

Suppliers and Packaging for NDA: 203503

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 203503 ANDA Glenmark Pharmaceuticals Inc., USA 68462-572 68462-572-13 3 BLISTER PACK in 1 CARTON (68462-572-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK
TABLET;ORAL 203503 ANDA Glenmark Pharmaceuticals Inc., USA 68462-572 68462-572-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-572-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 2, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 2, 2015TE:ABRLD:No

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