ANDA 210705, held by Ajanta Pharma Ltd. Fenofibrate.
As of Nov 14, 2026, ANDA 210705 (Fenofibrate (Micronized)), held by Ajanta Pharma Ltd, was first approved by FDA on Sep 10, 2018, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules, USP 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 10, 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 |
| Jun 3, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 15, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 10, 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
