Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050718
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50718s06lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50718s06ltr.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
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 208657 DR REDDYS LABS LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 203263 SUN PHARM

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 208657 DR REDDYS LABS LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 203263 SUN PHARM

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