ANDA 208709, held by Cipla. Fenofibrate.
As of Nov 14, 2026, ANDA 208709 (Fenofibrate), held by Cipla, was first approved by FDA on Dec 15, 2016, with 5 approved supplements and 0 published complete response letters.
Fenofibrate tablets 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 |
|---|---|---|---|
| Dec 15, 2016 | Original application | Approved | None posted |
| Fenofibrate48MG · tablet;oral | Fenofibrate | Rx |
| Fenofibrate145MG · tablet;oral | Fenofibrate | Rx |
| Aug 21, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 27, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 15, 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
