Application 050718

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXIL (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	INJECTABLE, LIPOSOMAL;INJECTION	20MG/10ML (2MG/ML)	Yes	No
002	DOXIL (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	INJECTABLE, LIPOSOMAL;INJECTION	50MG/25ML (2MG/ML)	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0063	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0067	DOXIL	doxorubicin hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome	Baxter Healthcare Corporation	NDA	Current
59676-960	DOXIL	doxorubicin hydrochloride	Janssen Products, LP	NDA	Current
59676-960	DOXIL	doxorubicin hydrochloride	Janssen Products, LP	NDA	Current
59676-966	Doxorubicin Hydrochloride liposome	doxorubicin hydrochloride	Janssen Products, LP	NDA	Current
59676-966	Doxorubicin Hydrochloride liposome	doxorubicin hydrochloride	Janssen Products, LP	NDA	Current
59676-966	Doxorubicin Hydrochloride liposome	doxorubicin hydrochloride	Janssen Products, LP	NDA	Current
59676-966	Doxorubicin Hydrochloride liposome	doxorubicin hydrochloride	Janssen Products, LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85359	SUPPL	2026-03-12
85333	SUPPL	2026-03-12
71041	SUPPL	2022-05-11
71027	SUPPL	2022-05-09
67007	SUPPL	2021-04-07
59694	SUPPL	2019-08-13
59692	SUPPL	2019-08-13
50611	SUPPL	2017-12-06
49020	SUPPL	2017-07-20
48428	SUPPL	2017-05-17
8095	SUPPL	2015-12-29
18106	SUPPL	2015-04-17
8094	SUPPL	2015-04-17
39176	SUPPL	2015-01-29
39175	SUPPL	2013-09-09
30356	SUPPL	2013-09-04
30355	SUPPL	2012-09-24
18105	SUPPL	2012-09-20
42688	SUPPL	2011-10-10
44786	SUPPL	2008-07-17
39174	SUPPL	2008-06-19
30354	SUPPL	2008-06-13
39172	SUPPL	2007-05-29
30353	SUPPL	2007-05-29
8093	SUPPL	2007-05-29
39173	SUPPL	2007-05-18
30352	SUPPL	2005-02-03
18104	SUPPL	2005-02-03
18103	SUPPL	2004-11-01
30351	SUPPL	2004-10-29
8092	SUPPL	2004-06-02
39171	SUPPL	1999-06-28
30350	SUPPL	1999-06-28

Application 050718

Related Records#

Application Products#

NDC Listings For This Application#

Documents#