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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062933
Company: HOSPIRA

Products on ANDA 062933

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062933

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1992	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-50	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
06/12/2012	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062933s032lbl.pdf
11/03/2015	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
11/30/2011	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062933s021lbl.pdf
05/27/2009	SUPPL-20	Labeling		Label is not available on this site.
02/01/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/2001	SUPPL-8	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/09/2001	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/04/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/15/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/18/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/25/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/10/1995	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/09/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 062933

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2012	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062933s032lbl.pdf
11/30/2011	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062933s021lbl.pdf

Therapeutic Equivalents for ANDA 062933

VANCOMYCIN HYDROCHLORIDE

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	216591	ASPIRO
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205780	EUGIA PHARMA
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	203300	HIKMA
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	215197	MEITHEAL
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	204107	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
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215195	MEITHEAL

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