Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020954
Company: OTSUKA PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUSULFEX BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 205139 ACTAVIS LLC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 209580 AMNEAL PHARMS CO
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 210448 APOTEX INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205106 ATHENEX INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 202259 LUITPOLD
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205184 MYLAN LABS LTD
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 207794 NEXUS PHARMS
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 207050 PHARMASCIENCE INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 210931 SHILPA MEDICARE LTD
BUSULFEX BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription Yes AP 020954 OTSUKA PHARM
MYLERAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 208536 MYLAN INSTITUTIONAL

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