Details for New Drug Application (NDA): 079150
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The generic ingredient in FLUCONAZOLE is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 079150
Tradename: | FLUCONAZOLE |
Applicant: | Aurobindo Pharma |
Ingredient: | fluconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 079150
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUCONAZOLE | fluconazole | FOR SUSPENSION;ORAL | 079150 | ANDA | NorthStar Rx LLC | 16714-695 | 16714-695-01 | 1 BOTTLE in 1 CARTON (16714-695-01) / 35 mL in 1 BOTTLE |
FLUCONAZOLE | fluconazole | FOR SUSPENSION;ORAL | 079150 | ANDA | NorthStar Rx LLC | 16714-696 | 16714-696-01 | 1 BOTTLE in 1 CARTON (16714-696-01) / 35 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 50MG/5ML | ||||
Approval Date: | Sep 18, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Sep 18, 2009 | TE: | AB | RLD: | No |
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