Tamsulosin Hydrochloride

ANDA 90408, held by Pharmobedient. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 90408 (Tamsulosin Hydrochloride), held by Pharmobedient, was first approved by FDA on Apr 27, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2010
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 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 7 submissions, including labeling and manufacturing supplements


Sep 30, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Jan 20, 2012	Supplement 5Labeling	Approved	None posted
Mar 28, 2011	Supplement 1Manufacturing	Approved	None posted
Apr 27, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90408
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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