Itraconazole

ANDA 208481, held by Apotex. Itraconazole.

As of Nov 15, 2026, ANDA 208481 (Itraconazole), held by Apotex, was first approved by FDA on Aug 2, 2019, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2019
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Aug 2, 2019	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Sep 11, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Jun 16, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Jun 16, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Sep 30, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Sep 30, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Aug 2, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 208481
Drugs@FDA: Overview at FDA
Company: Apotex

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