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Details for New Drug Application (NDA): 077523
NDA 077523 describes FLUCONAZOLE, which is a drug marketed by Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, West-ward Pharms Int, Apotex, Aurobindo Pharma, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Idt Australia Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, Zydus Pharms Usa Inc, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Renaissance Ssa Llc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Teva Pharms Usa, Baxter Hlthcare, Inforlife, and Teva Pharms, and is included in forty NDAs. It is available from thirty-nine suppliers. Additional details are available on the FLUCONAZOLE profile page.
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.
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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