ANDA 200264, held by Impax Labs Inc. Choline Fenofibrate.
As of Nov 14, 2026, ANDA 200264 (Fenofibric Acid), held by Impax Labs Inc, was first approved by FDA on Sep 7, 2016, with 4 approved supplements and 0 published complete response letters.
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 7, 2016 | Original application | Approved | None posted |
| Fenofibric AcidEQ 45MG FENOFIBRIC ACID · capsule, delayed release;oral | Choline Fenofibrate | Rx |
| Fenofibric AcidEQ 135MG FENOFIBRIC ACID · capsule, delayed release;oral | Choline Fenofibrate | Rx |
| Oct 8, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 29, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 23, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 23, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 7, 2016 | 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
