Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020954
Company: OTSUKA PHARM
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-Container/Carton Labels, Labeling-Package Insert |
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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/11/2020 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020954Orig1s020lbl.pdf | |
03/11/2020 | SUPPL-20 | Labeling-Package Insert | 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 |
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 | 215102 | EUGIA PHARMA |
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 | 215235 | PRINSTON INC |
BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210931 | SHILPA |
BUSULFEX | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020954 | OTSUKA PHARM |