Details for New Drug Application (NDA): 076087
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NDA 076087 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-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 076087
| Tradename: | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% |
| Applicant: | Hikma |
| Ingredient: | fluconazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 076087
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
| Approval Date: | Jul 29, 2004 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/50ML (2MG/ML) | ||||
| Approval Date: | Sep 26, 2008 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/200ML (2MG/ML) | ||||
| Approval Date: | Jul 29, 2004 | TE: | AP | RLD: | No | ||||
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