Tamsulosin Hydrochloride

ANDA 77630, held by Teva Pharms. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 77630 (Tamsulosin Hydrochloride), held by Teva Pharms, was first approved by FDA on Apr 27, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2010
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 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	Rx

All 4 submissions, including labeling and manufacturing supplements


Dec 8, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Dec 8, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Aug 30, 2011	Supplement 3Labeling	Approved	None posted
Apr 27, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 77630
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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