Busulfan

Product NDC

45963-640

11-digit product format

459630640

Labeler code

45963

Product ID

45963-640_ae7a687b-9248-4971-bdf9-0c48efea7550

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Busulfan

Dosage form

INJECTION, SOLUTION, CONCENTRATE

Route

INTRAVENOUS

Labeler

Actavis Pharma, Inc.

Application

ANDA205139

Marketing category

ANDA

Marketing start

2018-01-04

Marketing end

2021-01-31

Substance

BUSULFAN

Active strength

6 mg/mL

Pharmacologic classes

Alkylating Activity [MoA],Alkylating Drug [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record