ANDA 220147, held by Alkem Labs Ltd. Tolvaptan.
As of Nov 15, 2026, ANDA 220147 (Tolvaptan), held by Alkem Labs Ltd, was first approved by FDA on Apr 21, 2026, with 0 approved supplements and 0 published complete response letters.
Tolvaptan tablet is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 2026 | 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
