Triamcinolone Acetonide

ANDA 78104, held by Perrigo Pharma Intl. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 78104 (Triamcinolone Acetonide), held by Perrigo Pharma Intl, was first approved by FDA on Jul 30, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 30, 2009
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

nasal congestion
runny nose
sneezing
itchy nose

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 30, 2009	Original application	Approved	Letter Label

Products

2 strengths and forms


Triamcinolone Acetonide0.055MG/SPRAY · spray, metered;nasal	Triamcinolone Acetonide	Discontinued
Triamcinolone Acetonide0.055MG/SPRAY · spray, metered;nasal	Triamcinolone Acetonide	OTC

All 6 submissions, including labeling and manufacturing supplements


Nov 12, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Nov 12, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Nov 12, 2020	Supplement 17Labeling · Standard review	Approved	None posted
May 25, 2018	Supplement 7Manufacturing	Approved	None posted
Nov 14, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Jul 30, 2009	Original application	Approved	Letter Label

Identifiers

Application: ANDA 78104
Drugs@FDA: Overview at FDA
Company: Perrigo Pharma International

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