Manages angina pectoris. ANDA 201893, held by Aurobindo Pharma. Nadolol.
As of Nov 15, 2026, ANDA 201893 (Nadolol), held by Aurobindo Pharma, was first approved by FDA on Sep 16, 2015, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2015 | Original application | Approved |
| Mar 1, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 7, 2022 | Supplement 3Manufacturing | Approved | None posted |
| May 1, 2019 | Supplement 1Manufacturing | Approved | None posted |
| Sep 16, 2015 | Original application | Approved |
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
