ANDA 209504, held by Ani Pharms. Fenofibrate.
As of Nov 14, 2026, ANDA 209504 (Fenofibrate (Micronized)), held by Ani Pharms, was first approved by FDA on Apr 30, 2018, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2018 | Original application | Approved | None posted |
| Fenofibrate (Micronized)67MG · capsule;oral | Fenofibrate | Rx |
| Fenofibrate (Micronized)134MG · capsule;oral | Fenofibrate | Rx |
| Fenofibrate (Micronized)200MG · capsule;oral | Fenofibrate | Rx |
| May 25, 2022 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 15, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 13, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 30, 2018 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
