Busulfan

ANDA 207050, held by Pharmascience Inc. Busulfan.

As of Nov 14, 2026, ANDA 207050 (Busulfan), held by Pharmascience Inc, was first approved by FDA on Mar 24, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 24, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan Injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 24, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


May 21, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 8, 2019	Supplement 1Labeling · Standard review	Approved	None posted
May 8, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Mar 24, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207050
Drugs@FDA: Overview at FDA
Company: Pharmascience, Inc.

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