ANDA 212232, held by Aurobindo Pharma Ltd. Fenofibrate.
As of Nov 14, 2026, ANDA 212232 (Fenofibrate (Micronized)), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 20, 2021, with 0 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 |
|---|---|---|---|
| Sep 20, 2021 | 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 |
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
