Triamcinolone Acetonide

NDA 19503, held by Parnell. Triamcinolone Acetonide.

As of Nov 14, 2026, NDA 19503 (Triamcinolone Acetonide), held by Parnell, was first approved by FDA on Oct 16, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 16, 1987
Review: Standard
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
Oct 16, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Triamcinolone Acetonide3MG/ML · injectable;injection	Triamcinolone Acetonide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 14, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 16, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 16, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19503
Drugs@FDA: Overview at FDA
Company: Parnell 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