Details for New Drug Application (NDA): 205443
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NDA 205443 describes FEBUXOSTAT, which is a drug marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Indoco, Lupin Ltd, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, Torrent, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the FEBUXOSTAT profile page.
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.
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 205443
| Tradename: | FEBUXOSTAT |
| Applicant: | Zydus Lifesciences |
| Ingredient: | febuxostat |
| Patents: | 0 |
Pharmacology for NDA: 205443
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205443
Suppliers and Packaging for NDA: 205443
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEBUXOSTAT | febuxostat | TABLET;ORAL | 205443 | ANDA | Zydus Lifesciences Limited | 70771-1552 | 70771-1552-0 | 1000 TABLET in 1 BOTTLE (70771-1552-0) |
| FEBUXOSTAT | febuxostat | TABLET;ORAL | 205443 | ANDA | Zydus Lifesciences Limited | 70771-1552 | 70771-1552-1 | 100 TABLET in 1 BOTTLE (70771-1552-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jan 9, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Jan 9, 2023 | TE: | AB | RLD: | No | ||||
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