Tamsulosin Hydrochloride

Treats benign prostatic hyperplasia (BPH). ANDA 78015, held by Sandoz. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 78015 (Tamsulosin Hydrochloride), held by Sandoz, was first approved by FDA on Apr 27, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2010
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin hydrochloride capsules, USP are not indicated for the treatment of hypertension.

Tamsulosin hydrochloride capsule, USP is an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia
Tamsulosin hydrochloride capsules, USP 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 6 submissions below

Date	Submission	Status	Documents
Apr 27, 2010	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Sep 15, 2021	Supplement 13Manufacturing	Approved	None posted
Sep 15, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Oct 30, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Oct 27, 2011	Supplement 5Labeling	Approved	None posted
May 4, 2011	Supplement 3Labeling	Approved	None posted
Apr 27, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78015
Drugs@FDA: Overview at FDA
Company: Sandoz

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