Details for New Drug Application (NDA): 077731
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The generic ingredient in FLUCONAZOLE is fluconazole. There are twenty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 077731
Tradename: | FLUCONAZOLE |
Applicant: | Aurobindo Pharma |
Ingredient: | fluconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 077731
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUCONAZOLE | fluconazole | TABLET;ORAL | 077731 | ANDA | NorthStar Rx LLC | 16714-691 | 16714-691-01 | 30 TABLET in 1 BOTTLE (16714-691-01) |
FLUCONAZOLE | fluconazole | TABLET;ORAL | 077731 | ANDA | NorthStar Rx LLC | 16714-691 | 16714-691-02 | 100 TABLET in 1 BOTTLE (16714-691-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Oct 7, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Oct 7, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Oct 7, 2008 | TE: | AB | RLD: | No |
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