ANDA 211626, held by Rising. Choline Fenofibrate.
As of Nov 14, 2026, ANDA 211626 (Fenofibric Acid), held by Rising, was first approved by FDA on Jul 18, 2019, with 2 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 |
|---|---|---|---|
| Jul 18, 2019 | 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 |
| Aug 31, 2026 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 21, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 18, 2019 | 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
