Details for New Drug Application (NDA): 077909
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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-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 077909
Tradename: | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
Applicant: | Woodward |
Ingredient: | fluconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 077909
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 | 077909 | ANDA | Woodward Pharma Services LLC | 69784-261 | 69784-261-24 | 50 mL in 1 CONTAINER (69784-261-24) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
Approval Date: | May 26, 2010 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/200ML (2MG/ML) | ||||
Approval Date: | May 26, 2010 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/50ML (2MG/ML) | ||||
Approval Date: | Apr 20, 2015 | TE: | RLD: | No |
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