Manages angina pectoris. ANDA 203455, held by Invagen Pharms. Nadolol.
As of Nov 15, 2026, ANDA 203455 (Nadolol), held by Invagen Pharms, was first approved by FDA on Dec 18, 2015, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Angina Pectoris Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets, USP 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 2015 | Original application | Approved |
| Mar 1, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Dec 18, 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
