Details for New Drug Application (NDA): 205421
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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 205421
Tradename: | FEBUXOSTAT |
Applicant: | Alembic |
Ingredient: | febuxostat |
Patents: | 0 |
Pharmacology for NDA: 205421
Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205421
Suppliers and Packaging for NDA: 205421
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FEBUXOSTAT | febuxostat | TABLET;ORAL | 205421 | ANDA | Alembic Pharmaceuticals Limited | 46708-190 | 46708-190-08 | 80 TABLET, COATED in 1 CARTON (46708-190-08) |
FEBUXOSTAT | febuxostat | TABLET;ORAL | 205421 | ANDA | Alembic Pharmaceuticals Limited | 46708-190 | 46708-190-10 | 100 TABLET, COATED in 1 CARTON (46708-190-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jul 1, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Jul 1, 2019 | TE: | AB | RLD: | No |
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