Details for New Drug Application (NDA): 022118
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NDA 022118 describes FENOGLIDE, which is a drug marketed by Salix and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FENOGLIDE profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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 | Santarus, Inc. | 68012-490 | 68012-490-90 | 90 TABLET in 1 BOTTLE (68012-490-90) |
| FENOGLIDE | fenofibrate | TABLET;ORAL | 022118 | NDA | Santarus, Inc. | 68012-495 | 68012-495-07 | 6 BOTTLE in 1 BOX (68012-495-07) / 7 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Aug 10, 2007 | TE: | AB | RLD: | Yes | ||||
| Patent: | See Plans and Pricing | Patent Expiration: | Dec 9, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | 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: | See Plans and Pricing | 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 | ||||||||
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