Details for New Drug Application (NDA): 078698
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NDA 078698 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hikma Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, and Woodward, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Forty-four 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% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 078698
| Tradename: | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | fluconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078698
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078698 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9668 | 0143-9668-10 | 10 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01) |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078698 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9669 | 0143-9669-10 | 10 CONTAINER in 1 CARTON (0143-9669-10) / 100 mL in 1 CONTAINER (0143-9669-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
| Approval Date: | Jan 30, 2012 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/200ML (2MG/ML) | ||||
| Approval Date: | Jan 30, 2012 | TE: | AP | RLD: | No | ||||
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