For primary (heterozygous familial and non-familial) hyperlipidemia or mixed…. ANDA 208699, held by Glenmark Pharms Ltd. Ezetimibe; Simvastatin.
As of Nov 15, 2026, ANDA 208699 (Ezetimibe And Simvastatin), held by Glenmark Pharms Ltd, was first approved by FDA on Jun 27, 2019, with 4 approved supplements and 0 published complete response letters.
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2019 | Original application | Approved | None posted |
| Ezetimibe And Simvastatin10MG;10MG · tablet;oral | Ezetimibe; Simvastatin | Rx |
| Ezetimibe And Simvastatin10MG;20MG · tablet;oral | Ezetimibe; Simvastatin | Rx |
| Ezetimibe And Simvastatin10MG;40MG · tablet;oral | Ezetimibe; Simvastatin | Rx |
| Ezetimibe And Simvastatin10MG;80MG · tablet;oral | Ezetimibe; Simvastatin | Rx |
| Jun 10, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 10, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 2, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 24, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 27, 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
