An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020954
Company: OTSUKA PHARM

Products on NDA 020954

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUSULFEX	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020954

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/04/1999	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20954lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20954ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20954.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2020	SUPPL-20	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020954Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020954Orig1s020replacementltr.pdf
09/28/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020954Orig1s018,020954Orig1s019ltr.pdf
09/28/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020954Orig1s018,020954Orig1s019ltr.pdf
01/24/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020954Orig1s017ltr.pdf
05/19/2016	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020954s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020954Orig1s016ltr.pdf
10/28/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/16/2015	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020954s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020954Orig1s014ltr.pdf
09/04/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/23/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf
06/23/2011	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf
04/19/2007	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020954s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020954s008_LTR.pdf
11/13/2002	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20954scp005_busulfex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954scp005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-954s005_Busulfex.cfm
01/13/2003	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020954s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20954se2-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-954S004_Busulfex.cfm
04/24/2002	SUPPL-3	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954s003.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20954-S003_BUSULFEX.pdf
12/07/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/23/2002	SUPPL-1	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20954-S001_BUSULFEX.pdf

Labels for NDA 020954

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020954Orig1s020lbl.pdf
03/11/2020	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020954Orig1s020lbl.pdf
09/28/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s018s019lbl.pdf
09/28/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s018s019lbl.pdf
01/24/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s017lbl.pdf
05/19/2016	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020954s016lbl.pdf
01/16/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020954s014lbl.pdf
06/23/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf
06/23/2011	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf
04/19/2007	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020954s008lbl.pdf
04/19/2007	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020954s008lbl.pdf
01/13/2003	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020954s004lbl.pdf
11/13/2002	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20954scp005_busulfex_lbl.pdf
02/04/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20954lbl.pdf

Therapeutic Equivalents for NDA 020954

BUSULFEX

INJECTABLE;INJECTION; 6MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210148	ACCORD HLTHCARE INC
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209580	AMNEAL
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210448	APOTEX
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205672	HOSPIRA
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212127	MEITHEAL
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208536	MYLAN INSTITUTIONAL
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207050	PHARMASCIENCE INC
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210931	SHILPA
BUSULFEX	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020954	OTSUKA PHARM

Top