Details for New Drug Application (NDA): 022118
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The generic ingredient in FENOGLIDE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 022118
Tradename: | FENOGLIDE |
Applicant: | Salix |
Ingredient: | fenofibrate |
Patents: | 4 |
Suppliers and Packaging for NDA: 022118
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOGLIDE | fenofibrate | TABLET;ORAL | 022118 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals of New York LLC | 0115-1522 | 0115-1522-10 | 90 TABLET in 1 BOTTLE (0115-1522-10) |
FENOGLIDE | fenofibrate | TABLET;ORAL | 022118 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals of New York LLC | 0115-1523 | 0115-1523-10 | 90 TABLET in 1 BOTTLE (0115-1523-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Aug 10, 2007 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 9, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 1, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 1, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES |
Expired US Patents for NDA 022118
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-002 | Aug 10, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-002 | Aug 10, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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