Itraconazole

ANDA 204672, held by Zydus Pharms. Itraconazole.

As of Nov 15, 2026, ANDA 204672 (Itraconazole), held by Zydus Pharms, was first approved by FDA on Sep 19, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 19, 2017
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 19, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Itraconazole100MG · capsule;oral	Itraconazole	Rx

All 5 submissions, including labeling and manufacturing supplements


Jun 12, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Oct 4, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Oct 4, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Oct 4, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 19, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204672
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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