Details for New Drug Application (NDA): 211122
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The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 211122
Tradename: | FENOFIBRATE |
Applicant: | Rising |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 211122
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 211122 | ANDA | Laurus Labs Limited | 42385-950 | 42385-950-11 | 1000 TABLET in 1 BOTTLE (42385-950-11) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 211122 | ANDA | Laurus Labs Limited | 42385-950 | 42385-950-30 | 30 TABLET in 1 BOTTLE (42385-950-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 48MG | ||||
Approval Date: | Mar 18, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 145MG | ||||
Approval Date: | Mar 18, 2020 | TE: | AB | RLD: | No |
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