Triamcinolone Acetonide

Relieves symptoms associated with oral inflammatory lesions and ulcerative lesions…. ANDA 70730, held by Sun Pharma Canada. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 70730 (Triamcinolone Acetonide), held by Sun Pharma Canada, was first approved by FDA on Oct 1, 1986, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 1, 1986
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Triamcinolone Acetonide Dental Paste USP, 0.1% is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 1, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Triamcinolone Acetonide0.1% · paste;dental	Triamcinolone Acetonide	Rx

All 14 submissions, including labeling and manufacturing supplements


Jan 27, 2011	Supplement 21Manufacturing	Approved	None posted
Jun 8, 2006	Supplement 15Labeling	Approved	None posted
Oct 22, 1996	Supplement 11Manufacturing	Approved	None posted
Sep 17, 1996	Supplement 10Manufacturing	Approved	None posted
May 14, 1996	Supplement 9Manufacturing	Approved	None posted
May 14, 1996	Supplement 8Manufacturing	Approved	None posted
Apr 26, 1994	Supplement 7Manufacturing	Approved	None posted
Jul 29, 1992	Supplement 6Labeling	Approved	None posted
Mar 7, 1990	Supplement 5Manufacturing	Approved	None posted
Feb 13, 1989	Supplement 4Manufacturing	Approved	None posted
Aug 4, 1988	Supplement 1Labeling	Approved	None posted
May 24, 1988	Supplement 3Manufacturing	Approved	None posted
Mar 24, 1988	Supplement 2Manufacturing	Approved	None posted
Oct 1, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70730
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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