اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20954lbl.pdf |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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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