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Details for New Drug Application (NDA): 206837

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NDA 206837 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: 206837

Tradename:
VORICONAZOLE
Applicant:
Aurobindo Pharma Ltd
Ingredient:
voriconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206837

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE
voriconazole
TABLET;ORAL 206837 ANDA Aurobindo Pharma Limited 65862-891 65862-891-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-891-01)
VORICONAZOLE
voriconazole
TABLET;ORAL 206837 ANDA Aurobindo Pharma Limited 65862-891 65862-891-03 3 BLISTER PACK in 1 CARTON (65862-891-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-891-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 22, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 22, 2016TE:ABRLD:No


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