ANDA 205646, held by Hetero Labs Ltd V. Tolvaptan.
As of Nov 14, 2026, ANDA 205646 (Tolvaptan), held by Hetero Labs Ltd V, was first approved by FDA on Sep 6, 2022, with 0 approved supplements 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 provide a symptomatic benefit to patients.
| Sep 6, 2022 | Original application | Approved | None posted |
| Jul 16, 2021 | Original application | Approved | None posted |
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