Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062663
Company: FRESENIUS KABI USA
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
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/17/1987 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
07/12/2017 SUPPL-85 Labeling-Package Insert

Label is not available on this site.

07/12/2017 SUPPL-83 Labeling-Package Insert

Label is not available on this site.

02/16/2016 SUPPL-57 Labeling

Label is not available on this site.

02/16/2016 SUPPL-55 Labeling

Label is not available on this site.

02/16/2016 SUPPL-42 Labeling

Label is not available on this site.

12/05/2002 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/2002 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2001 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

12/13/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2000 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/11/2000 SUPPL-28 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/13/2000 SUPPL-27 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/13/2000 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/11/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/28/1997 SUPPL-20 Labeling

Label is not available on this site.

11/28/1997 SUPPL-19 Manufacturing (CMC)-New Strength

Label is not available on this site.

07/05/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/12/1996 SUPPL-17 Labeling

Label is not available on this site.

04/03/1995 SUPPL-16 Labeling

Label is not available on this site.

08/04/1992 SUPPL-15 Labeling

Label is not available on this site.

11/30/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/20/1990 SUPPL-10 Labeling

Label is not available on this site.

06/07/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/23/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/11/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/03/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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 205780 AUROBINDO PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202275 EMCURE PHARMS LTD
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 065401 MUSTAFA NEVZAT ILAC
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 090250 SANDOZ
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204107 XELLIA PHARMS APS

INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205780 AUROBINDO PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202275 EMCURE PHARMS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062663 FRESENIUS KABI USA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205694 GLAND PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212332 HAINAN POLY PHARM
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062912 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062933 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065401 MUSTAFA NEVZAT ILAC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065397 MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090250 SANDOZ
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204107 XELLIA PHARMS APS

INJECTABLE;INJECTION; EQ 5GM 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 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205779 AUROBINDO PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202274 EMCURE PHARMS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062663 FRESENIUS KABI USA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204360 HIKMA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 063076 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065432 MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200837 SAGENT PHARMS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201048 SANDOZ INC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204125 XELLIA PHARMS APS

INJECTABLE;INJECTION; EQ 10GM 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 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205779 AUROBINDO PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202464 EMCURE PHARMS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062663 FRESENIUS KABI USA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204360 HIKMA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065455 HOSPIRA INC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091554 MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200837 SAGENT PHARMS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201048 SANDOZ INC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204125 XELLIA PHARMS APS

INJECTABLE;INJECTION; EQ 750MG 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 750MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062663 FRESENIUS KABI USA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206616 HIKMA PHARMS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062912 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062933 HOSPIRA

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