Application 050671

Type: NDA
Sponsor: BAXTER HLTHCARE

Related Records

Company: BAXTER HLTHCARE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/100ML	Yes	Yes
002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 750MG BASE/150ML	Yes	Yes
003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/200ML	Yes	Yes
004	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	Yes	Yes
005	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current

Documents

Document	Submission type	Date
82368	ORIG	2025-05-30
82367	SUPPL	2025-05-30
82361	SUPPL	2025-05-30
78752	SUPPL	2024-07-02
78760	SUPPL	2024-06-10
66045	SUPPL	2021-02-01
66031	SUPPL	2021-02-01
49893	SUPPL	2017-09-29
49879	SUPPL	2017-09-29
46852	SUPPL	2017-01-17
46767	SUPPL	2017-01-06
17999	SUPPL	2015-12-28
7966	SUPPL	2015-12-22
17998	SUPPL	2012-01-23
7965	SUPPL	2012-01-19
39086	SUPPL	2009-04-03
30250	SUPPL	2009-03-13
39085	SUPPL	2008-05-08
7964	SUPPL	2008-05-07
30249	SUPPL	2007-09-25
39084	SUPPL	2007-09-19
7963	SUPPL	2004-04-07
17997	SUPPL	2004-04-05
42672	SUPPL	1998-01-08
42671	SUPPL	1998-01-08