ANDA 216933, held by Teva Pharms Inc. Tolvaptan.
As of Nov 15, 2026, ANDA 216933 (Tolvaptan), held by Teva Pharms Inc, was first approved by FDA on Jul 21, 2026, with 0 approved supplements and 0 published complete response letters.
Tolvaptan tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 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
