Tamsulosin Hydrochloride

Treats benign prostatic hyperplasia (BPH). ANDA 90377, held by Impax Labs. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 90377 (Tamsulosin Hydrochloride), held by Impax Labs, was first approved by FDA on Mar 2, 2010, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 2, 2010
Supplements approved: 2
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 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 3 submissions below

Date	Submission	Status	Documents
Mar 2, 2010	Original application	Approved	Letter

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jul 25, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Oct 31, 2011	Supplement 3Labeling	Approved	None posted
Mar 2, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 90377
Drugs@FDA: Overview at FDA
Company: Impax 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