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, 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-six 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-six 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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