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Details for New Drug Application (NDA): 076736
NDA 076736 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma Farmaceutica, Teva Pharms Usa, West-ward Pharms Int, Baxter Hlthcare, Hospira, Inforlife, Mylan Labs Ltd, Renaissance Ssa Llc, and Teva Pharms, and is included in fourteen NDAs. It is available from one supplier. Additional details are available on the FLUCONAZOLE IN SODIUM CHLORIDE 0.9% profile page.
The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% is fluconazole. There are twenty-three drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% is fluconazole. There are twenty-three drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 076736
| Tradename: | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | fluconazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076736
| Ingredient-type | Azoles |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 2C9 Inhibitors |
Medical Subject Heading (MeSH) Categories for 076736
Suppliers and Packaging for NDA: 076736
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | fluconazole | INJECTABLE;INJECTION | 076736 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9899 | 0143-9899-91 | 6 VIAL in 1 CARTON (0143-9899-91) > 100 mL in 1 VIAL (0143-9899-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
| Approval Date: | Aug 23, 2005 | TE: | AP | RLD: | No | ||||
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