BUSULFEX از شرکت OTSUKA PHARM

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BUSULFEX از شرکت OTSUKA PHARM

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
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-Package Insert, Labeling-Container/Carton Labels

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
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-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020954s008lbl.pdf
04/19/2007 SUPPL-8

Labeling-Container/Carton Labels

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 202259 AM REGENT
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 205106 ATHENEX INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205672 HOSPIRA INC
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 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
BUSULFEX BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription Yes AP 020954 OTSUKA PHARM
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