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As of Nov 15, 2026, ANDA 216063 (Tolvaptan), held by Lupin, was first approved by FDA on Apr 23, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Apr 23, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Tolvaptan tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
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
