Details for New Drug Application (NDA): 021612
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The generic ingredient in LIPOFEN is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021612
Tradename: | LIPOFEN |
Applicant: | Cipher Pharms Inc |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612 | NDA | ANI Pharmaceuticals, Inc. | 62559-305 | 62559-305-90 | 90 CAPSULE in 1 BOTTLE (62559-305-90) |
LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612 | NDA | ANI Pharmaceuticals, Inc. | 62559-306 | 62559-306-90 | 90 CAPSULE in 1 BOTTLE (62559-306-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jan 11, 2006 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jan 11, 2006 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 11, 2006 | TE: | RLD: | Yes |
Expired US Patents for NDA 021612
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-001 | Jan 11, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-003 | Jan 11, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-002 | Jan 11, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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