Striant

NDA 21543, held by Auxilium Pharms LLC. Testosterone.

As of Nov 14, 2026, NDA 21543 (Striant), held by Auxilium Pharms LLC, was first approved by FDA on Jun 19, 2003, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2003
Review: Standard
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
Jun 19, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Striant30MG · tablet, extended release;buccal	Testosterone	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Oct 25, 2016	Supplement 12Labeling · Standard review	Approved	Label Letter
May 11, 2015	Supplement 11Labeling · Standard review	Approved	Letter Label
Jun 19, 2014	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 21, 2014	Supplement 9Labeling	Approved	Letter Label
Nov 5, 2004	Supplement 2Manufacturing · Standard review	Approved	Label Letter
Nov 3, 2003	Supplement 1Labeling · Standard review	Approved	Letter
Jun 19, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21543
Drugs@FDA: Overview at FDA
Company: Auxilium 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