Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050718
Company: BAXTER HLTHCARE CORP

• Summary Review

Products on NDA 50718

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

Labels for NDA 050718

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2022	SUPPL-60	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050718Orig1s060lbl.pdf
05/06/2022	SUPPL-60	Labeling-Container/Carton Labels	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