Treats hypertension. ANDA 78906, held by Glenmark Pharms Ltd. Verapamil Hydrochloride.
As of Nov 15, 2026, ANDA 78906 (Verapamil Hydrochloride), held by Glenmark Pharms Ltd, was first approved by FDA on Sep 17, 2009, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Verapamil hydrochloride extended-release 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 this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Verapamil Hydrochloride240MG · tablet, extended release;oral | Verapamil Hydrochloride | Rx |
| Dec 22, 2021 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 26, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 26, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 6, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 6, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 7, 2010 | Supplement 1Manufacturing | Approved | None posted |
| Sep 17, 2009 | 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
