Details for New Drug Application (NDA): 076077
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The generic ingredient in FLUCONAZOLE 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 076077
Tradename: | FLUCONAZOLE |
Applicant: | Ivax Sub Teva Pharms |
Ingredient: | fluconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 076077
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUCONAZOLE | fluconazole | TABLET;ORAL | 076077 | ANDA | Proficient Rx LP | 63187-613 | 63187-613-01 | 1 TABLET in 1 BLISTER PACK (63187-613-01) |
FLUCONAZOLE | fluconazole | TABLET;ORAL | 076077 | ANDA | Proficient Rx LP | 71205-573 | 71205-573-10 | 10 TABLET in 1 BOTTLE (71205-573-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 29, 2004 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 29, 2004 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jul 29, 2004 | TE: | RLD: | No |
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