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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062911
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No 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
08/04/1988 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2021 SUPPL-61 Labeling-Package Insert

Label is not available on this site.
09/01/2020 SUPPL-55 Labeling-Package Insert

Label is not available on this site.
09/01/2020 SUPPL-47 Labeling-Package Insert

Label is not available on this site.
04/13/2017 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
09/01/2020 SUPPL-43 Labeling-Package Insert

Label is not available on this site.
05/08/2012 SUPPL-42 Labeling-Package Insert

Label is not available on this site.
11/30/2011 SUPPL-35 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062911s035lbl.pdf
11/18/2008 SUPPL-32 Labeling

Label is not available on this site.
08/21/2008 SUPPL-16 Labeling

Label is not available on this site.
10/04/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
02/01/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/2001 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
07/14/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
12/09/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
11/13/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/22/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
07/23/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
12/05/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
12/05/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/30/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062911s035lbl.pdf

VANCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 216591 ASPIRO
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205780 EUGIA PHARMA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062663 FRESENIUS KABI USA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205694 GLAND PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212332 HAINAN POLY PHARM
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062911 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062931 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 215197 MEITHEAL
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065397 MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204107 XELLIA PHARMS APS
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