Details for New Drug Application (NDA): 206837
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The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 206837
Tradename: | VORICONAZOLE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | voriconazole |
Patents: | 0 |
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 | NorthStar Rx LLC | 16714-198 | 16714-198-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-198-01) |
VORICONAZOLE | voriconazole | TABLET;ORAL | 206837 | ANDA | NorthStar Rx LLC | 16714-199 | 16714-199-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-199-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jan 22, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jan 22, 2016 | TE: | AB | RLD: | No |
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