Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050718
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | AB | Yes | No |
| DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/17/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/06/2022 | SUPPL-60 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050718Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050718Orig1s060ltr.pdf | |
| 08/12/2019 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050718s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050718Orig1s055ltr.pdf | |
| 03/29/2016 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050718s051lbl.pdf | |
| 12/28/2015 | SUPPL-50 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050718Orig1s050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/050718Orig1s050.pdf |
| 10/09/2015 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2015 | SUPPL-48 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050718Orig1s048ltr.pdf | |
| 04/14/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/2015 | SUPPL-46 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/050718Orig1s046.pdf | |
| 08/30/2013 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050718s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050718Orig1s045ltr.pdf | |
| 09/19/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050718s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050718Orig1s043ltr.pdf | |
| 06/10/2008 | SUPPL-33 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050718s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050718s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/050718se7-033_SUMR.pdf | |
| 12/12/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2007 | SUPPL-29 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf | |
| 05/17/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf | |
| 01/28/2005 | SUPPL-20 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50718s019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50718s019,020ltr.pdf | |
| 10/27/2004 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50718s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50718s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050718Orig1s019.pdf | |
| 12/17/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2002 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/18/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50718s10ltr.pdf |
| 06/13/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1999 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50718s06lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50718s06ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/050718Orig1s006.pdf | |
| 03/31/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/10/1996 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/08/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/06/2022 | SUPPL-60 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050718Orig1s060lbl.pdf | |
| 05/06/2022 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050718Orig1s060lbl.pdf | |
| 08/12/2019 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050718s055lbl.pdf | |
| 03/29/2016 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050718s051lbl.pdf | |
| 04/16/2015 | SUPPL-48 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s048lbl.pdf | |
| 01/22/2015 | SUPPL-46 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s046lbl.pdf |
| 08/30/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050718s045lbl.pdf | |
| 09/19/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050718s043lbl.pdf | |
| 06/10/2008 | SUPPL-33 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050718s033lbl.pdf | |
| 05/17/2007 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s029lbl.pdf | |
| 05/17/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s028s029lbl.pdf | |
| 01/28/2005 | SUPPL-20 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50718s019,020lbl.pdf | |
| 10/27/2004 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50718s019lbl.pdf | |
| 06/28/1999 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50718s06lbl.pdf |
DOXIL (LIPOSOMAL)
INJECTABLE, LIPOSOMAL;INJECTION; 20MG/10ML (2MG/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AB | 050718 | BAXTER HLTHCARE CORP |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 207228 | AYANA PHARMA LTD |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212219 | CELERITY PHARMS |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 208657 | DR REDDYS |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 203263 | SUN PHARM |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212299 | ZYDUS |
INJECTABLE, LIPOSOMAL;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AB | 050718 | BAXTER HLTHCARE CORP |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 207228 | AYANA PHARMA LTD |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212219 | CELERITY PHARMS |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 208657 | DR REDDYS |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 203263 | SUN PHARM |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212299 | ZYDUS |