Busulfan

ANDA 208536, held by Mylan Institutional. Busulfan.

As of Nov 14, 2026, ANDA 208536 (Busulfan), held by Mylan Institutional, was first approved by FDA on Nov 20, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 20, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Busulfan6MG/ML · injectable;injection	Busulfan	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 12, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Aug 12, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Nov 20, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208536
Drugs@FDA: Overview at FDA
Company: Mylan Institutional

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