ANDA 210786, held by Ingenus Pharms LLC. Nadolol.
As of Nov 15, 2026, ANDA 210786 (Nadolol), held by Ingenus Pharms LLC, was first approved by FDA on Jun 1, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2018 | Original application | Approved | None posted |
| May 31, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 1, 2018 | 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