Details for New Drug Application (NDA): 209504
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The generic ingredient in FENOFIBRATE (MICRONIZED) 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 209504
Tradename: | FENOFIBRATE (MICRONIZED) |
Applicant: | Ani Pharms |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209504
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 209504 | ANDA | ANI Pharmaceuticals, Inc. | 43975-305 | 43975-305-10 | 100 CAPSULE in 1 BOTTLE (43975-305-10) |
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 209504 | ANDA | ANI Pharmaceuticals, Inc. | 43975-305 | 43975-305-50 | 500 CAPSULE in 1 BOTTLE (43975-305-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 67MG | ||||
Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 134MG | ||||
Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No |
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