Details for New Drug Application (NDA): 076736
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NDA 076736 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Baxter Hlthcare, Hospira, Inforlife, Mylan Labs Ltd, and Woodward, 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. Forty-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. Forty-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 |
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 | Hikma Pharmaceuticals USA Inc. | 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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