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 Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, West-ward Pharms Int, 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-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% IN PLASTIC CONTAINER 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 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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