Tamsulosin Hydrochloride

Treats benign prostatic hyperplasia (BPH). ANDA 214730, held by Ascent Pharms Inc. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 214730 (Tamsulosin Hydrochloride), held by Ascent Pharms Inc, was first approved by FDA on May 4, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: May 4, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 4, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tamsulosin Hydrochloride0.4MG · capsule;oral	Tamsulosin Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 18, 2025	Supplement 3Manufacturing	Approved	None posted
May 4, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 214730
Drugs@FDA: Overview at FDA
Company: Ascent Pharmaceuticals, Inc.

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