Tamsulosin Hydrochloride

ANDA 202010, held by Ph Health. Tamsulosin Hydrochloride.

As of Nov 15, 2026, ANDA 202010 (Tamsulosin Hydrochloride), held by Ph Health, was first approved by FDA on Jan 4, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 4, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 4, 2013	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Nov 16, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 16, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jan 4, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202010
Drugs@FDA: Overview at FDA
Company: PH Health

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