Details for New Drug Application (NDA): 207293
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The generic ingredient in FEBUXOSTAT is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
Summary for 207293
| Tradename: | FEBUXOSTAT |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | febuxostat |
| Patents: | 0 |
Pharmacology for NDA: 207293
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207293
Suppliers and Packaging for NDA: 207293
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEBUXOSTAT | febuxostat | TABLET;ORAL | 207293 | ANDA | Macleods Pharmaceuticals Limited | 33342-274 | 33342-274-07 | 30 FILM in 1 BOTTLE (33342-274-07) |
| FEBUXOSTAT | febuxostat | TABLET;ORAL | 207293 | ANDA | Macleods Pharmaceuticals Limited | 33342-274 | 33342-274-10 | 90 FILM in 1 BOTTLE (33342-274-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Sep 28, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Sep 28, 2023 | TE: | AB | RLD: | No | ||||
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