An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Products on ANDA 062911

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062911

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.

Labels for ANDA 062911

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

Therapeutic Equivalents for ANDA 062911

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	065401	EUROFARMA
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
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204107	HIKMA
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	212332	SLATE RUN PHARMA

Top