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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050671
Company: BAXTER HLTHCARE

Products on NDA 050671

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050671

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1993	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/050671s036lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2026	SUPPL-43	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050671s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/050671Orig1s043ltr.pdf
05/29/2025	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050671s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050671Orig1s036ltr.pdf
06/07/2024	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050671s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050671Orig1s032ltr.pdf
01/29/2021	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050671s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050671Orig1s031ltr.pdf
09/28/2017	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050671Orig1s024ltr.pdf
01/09/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050671Orig1s023ltr.pdf
12/18/2015	SUPPL-22	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050671Orig1s022ltr.pdf
11/13/2015	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
01/17/2012	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050671s018ltr.pdf
03/11/2009	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050671s014ltr.pdf
05/02/2008	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050671s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050671s012ltr.pdf
09/17/2007	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050671s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050671s010ltr.pdf
03/30/2004	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50671slr006ltr.pdf
03/01/1999	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
01/08/1998	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf
11/07/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/08/1998	SUPPL-2	Efficacy-New Patient Population	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf
07/30/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 050671

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2026	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050671s043lbl.pdf
05/29/2025	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050671s036lbl.pdf
06/07/2024	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050671s032lbl.pdf
01/29/2021	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050671s031lbl.pdf
09/28/2017	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s024lbl.pdf
01/09/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s023lbl.pdf
12/18/2015	SUPPL-22	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf
01/17/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf
03/11/2009	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf
05/02/2008	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050671s012lbl.pdf
09/17/2007	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050671s010lbl.pdf
03/30/2004	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.pdf
04/29/1993	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/050671s036lbl.pdf

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