ANDA 211891, held by Alkem Labs Ltd. Tolvaptan.
As of Nov 14, 2026, ANDA 211891 (Tolvaptan), held by Alkem Labs Ltd, was first approved by FDA on Sep 6, 2022, with 1 approved supplement and 0 published complete response letters.
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.
| Sep 6, 2022 | Original application | Approved | None posted |
| May 19, 2020 | Original application | Approved |
| Sep 6, 2022 | Original application | Approved | None posted |
| Mar 28, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 19, 2020 | Original application | Approved |
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
