Itraconazole

Treats oropharyngeal and esophageal candidiasis. ANDA 212239, held by Annora Pharma. Itraconazole.

As of Nov 15, 2026, ANDA 212239 (Itraconazole), held by Annora Pharma, was first approved by FDA on Sep 1, 2020, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 1, 2020
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 1, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Itraconazole10MG/ML · solution;oral	Itraconazole	Rx

All 5 submissions, including labeling and manufacturing supplements


Mar 28, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jan 29, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Jan 29, 2025	Supplement 2Labeling · Standard review	Approved	None posted
May 26, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Sep 1, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 212239
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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