Treats hypertension. ANDA 213052, held by Aurobindo Pharma Ltd. Prazosin Hydrochloride.
As of Nov 15, 2026, ANDA 213052 (Prazosin Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 31, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prazosin hydrochloride capsules 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 |
|---|---|---|---|
| Mar 31, 2023 | Original application | Approved | None posted |
| Prazosin HydrochlorideEQ 1MG BASE · capsule;oral | Prazosin Hydrochloride | Rx |
| Prazosin HydrochlorideEQ 2MG BASE · capsule;oral | Prazosin Hydrochloride | Rx |
| Prazosin HydrochlorideEQ 5MG BASE · capsule;oral | Prazosin Hydrochloride | Rx |
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
