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Details for New Drug Application (NDA): 207371

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NDA 207371 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-two suppliers. Additional details are available on the VORICONAZOLE profile page.

The generic ingredient in VORICONAZOLE is voriconazole. There are eleven drug master file entries for this compound. Twenty-four 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: 207371

Tradename:
VORICONAZOLE
Applicant:
Novel Labs Inc
Ingredient:
voriconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 207371

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE
voriconazole
TABLET;ORAL 207371 ANDA Novel Laboratories, Inc. 40032-088 40032-088-03 30 TABLET, FILM COATED in 1 BOTTLE (40032-088-03)
VORICONAZOLE
voriconazole
TABLET;ORAL 207371 ANDA Novel Laboratories, Inc. 40032-088 40032-088-05 500 TABLET, FILM COATED in 1 BOTTLE (40032-088-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 24, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 24, 2016TE:ABRLD:No


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