Tamsulosin Hydrochloride

Treats benign prostatic hyperplasia (BPH). ANDA 207405, held by Alkem Labs Ltd. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 207405 (Tamsulosin Hydrochloride), held by Alkem Labs Ltd, was first approved by FDA on Aug 11, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 11, 2017
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 is 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
Aug 11, 2017	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


Sep 23, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Aug 11, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207405
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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