Itraconazole

ANDA 200463, held by Mylan Pharms Inc. Itraconazole.

As of Nov 15, 2026, ANDA 200463 (Itraconazole), held by Mylan Pharms Inc, was first approved by FDA on Jul 20, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2012
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 20, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Itraconazole100MG · capsule;oral	Itraconazole	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Oct 11, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 8Labeling · Standard review	Approved	None posted
May 16, 2016	Supplement 1Labeling · Standard review	Approved	None posted
May 16, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Jul 20, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200463
Drugs@FDA: Overview at FDA
Company: Mylan 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