Details for New Drug Application (NDA): 021656
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The generic ingredient in TRICOR is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021656
| Tradename: | TRICOR |
| Applicant: | Abbvie |
| Ingredient: | fenofibrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021656
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRICOR | fenofibrate | TABLET;ORAL | 021656 | NDA | AbbVie Inc. | 0074-3189 | 0074-3189-90 | 90 TABLET in 1 BOTTLE (0074-3189-90) |
| TRICOR | fenofibrate | TABLET;ORAL | 021656 | NDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-272 | 43353-272-30 | 30 TABLET in 1 BOTTLE (43353-272-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 5, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 5, 2004 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021656
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-001 | Nov 5, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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