Oralone

ANDA 71383, held by Sun Pharma Canada. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 71383 (Oralone), held by Sun Pharma Canada, was first approved by FDA on Jul 6, 1987, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1987
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 6, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oralone0.1% · paste;dental	Triamcinolone Acetonide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 13, 1992	Supplement 6Labeling	Approved	None posted
Mar 9, 1990	Supplement 4Manufacturing	Approved	None posted
Dec 28, 1988	Supplement 2Labeling	Approved	None posted
Jul 6, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71383
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