DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077523
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 077523
Tradename: | FLUCONAZOLE |
Applicant: | Ivax Sub Teva Pharms |
Ingredient: | fluconazole |
Patents: | 0 |
Therapeutic Class: | Antifungals |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077523
Ingredient-type | Azoles |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 2C9 Inhibitors |
Medical Subject Heading (MeSH) Categories for 077523
Suppliers and Packaging for NDA: 077523
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUCONAZOLE | fluconazole | FOR SUSPENSION;ORAL | 077523 | ANDA | Teva Pharmaceuticals USA Inc | 0093-5414 | N | 0093-5414-95 |
FLUCONAZOLE | fluconazole | FOR SUSPENSION;ORAL | 077523 | ANDA | Teva Pharmaceuticals USA Inc | 0093-5415 | N | 0093-5415-95 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 50MG/5ML | ||||
Approval Date: | Sep 12, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Sep 12, 2007 | TE: | AB | RLD: | No |
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