Torsemide

ANDA 76226, held by Strides Pharma Intl. Torsemide.

As of Nov 15, 2026, ANDA 76226 (Torsemide), held by Strides Pharma Intl, was first approved by FDA on May 27, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: May 27, 2003
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
May 27, 2003	Original application	Approved	None posted

Products

4 strengths and forms


Torsemide5MG · tablet;oral	Torsemide	Discontinued
Torsemide10MG · tablet;oral	Torsemide	Discontinued
Torsemide20MG · tablet;oral	Torsemide	Discontinued
Torsemide100MG · tablet;oral	Torsemide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 16, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Jun 16, 2005	Supplement 2Labeling	Approved	None posted
May 27, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76226
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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