Details for New Drug Application (NDA): 205414
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The generic ingredient in FEBUXOSTAT is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
Summary for 205414
Tradename: | FEBUXOSTAT |
Applicant: | Hikma |
Ingredient: | febuxostat |
Patents: | 0 |
Pharmacology for NDA: 205414
Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205414
Suppliers and Packaging for NDA: 205414
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FEBUXOSTAT | febuxostat | TABLET;ORAL | 205414 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0413 | 0054-0413-13 | 30 TABLET in 1 BOTTLE (0054-0413-13) |
FEBUXOSTAT | febuxostat | TABLET;ORAL | 205414 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0414 | 0054-0414-13 | 30 TABLET in 1 BOTTLE (0054-0414-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Oct 15, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Oct 15, 2019 | TE: | AB | RLD: | No |
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