Details for New Drug Application (NDA): 078764
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NDA 078764 describes FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Hikma Farmaceutica, Hospira, Norvium Bioscience, and Woodward, and is included in four NDAs. It is available from one supplier. Additional details are available on the FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
The generic ingredient in FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 078764
| Tradename: | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | fluconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078764
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078764 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9666 | 0143-9666-06 | 6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01) |
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078764 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9667 | 0143-9667-06 | 6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
| Approval Date: | Jan 30, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/200ML (2MG/ML) | ||||
| Approval Date: | Jan 30, 2012 | TE: | RLD: | No | |||||
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