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, West-ward Pharms Int, 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-five 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-five 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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