Treats hypertension. ANDA 210302, held by Alembic. Candesartan Cilexetil.
As of Nov 15, 2026, ANDA 210302 (Candesartan Cilexetil), held by Alembic, was first approved by FDA on Dec 4, 2018, with 1 approved supplement and 0 published complete response letters.
Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. · Treatment of heart failure (NYHA class II-IV); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization. 1.1 Hypertension Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 4, 2018 | Original application | Approved | None posted |
| Candesartan Cilexetil4MG · tablet;oral | Candesartan Cilexetil | Rx |
| Candesartan Cilexetil8MG · tablet;oral | Candesartan Cilexetil | Rx |
| Candesartan Cilexetil16MG · tablet;oral | Candesartan Cilexetil | Rx |
| Mar 4, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 4, 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
