Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050671
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML INJECTABLE;INJECTION Prescription None Yes Yes
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML INJECTABLE;INJECTION Prescription None Yes Yes
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML INJECTABLE;INJECTION Prescription None Yes Yes
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 is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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