Details for New Drug Application (NDA): 021856
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The generic ingredient in ULORIC 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 021856
Tradename: | ULORIC |
Applicant: | Takeda Pharms Usa |
Ingredient: | febuxostat |
Patents: | 3 |
Pharmacology for NDA: 021856
Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021856
Suppliers and Packaging for NDA: 021856
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ULORIC | febuxostat | TABLET;ORAL | 021856 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-677 | 64764-677-11 | 10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK |
ULORIC | febuxostat | TABLET;ORAL | 021856 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-677 | 64764-677-13 | 100 TABLET in 1 BOTTLE (64764-677-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Feb 13, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE |
Expired US Patents for NDA 021856
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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