Spironolactone

Helps diagnose primary hyperaldosteronism. ANDA 40424, held by Mylan. Spironolactone.

As of Nov 15, 2026, ANDA 40424 (Spironolactone), held by Mylan, was first approved by FDA on Aug 20, 2001, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 20, 2001
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Spironolactone tablets are indicated in the management of: Primary Hyperaldosteronism for Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 20, 2001	Original application	Approved	Label Review Letter

Products

3 strengths and forms


Spironolactone25MG · tablet;oral	Spironolactone	Rx
Spironolactone50MG · tablet;oral	Spironolactone	Rx
Spironolactone100MG · tablet;oral	Spironolactone	Rx

All 11 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 36Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 33Labeling · Standard review	Approved	None posted
Feb 26, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Apr 26, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Sep 23, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Sep 23, 2014	Supplement 17Labeling · Standard review	Approved	None posted
Feb 25, 2009	Supplement 11Labeling	Approved	None posted
Jun 9, 2003	Supplement 4Labeling	Approved	None posted
May 21, 2002	Supplement 1Manufacturing	Approved	None posted
Aug 20, 2001	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 40424
Drugs@FDA: Overview at FDA
Company: Mylan

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