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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063076
Company: HOSPIRA

Products on ANDA 063076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063076

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/1990	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-43	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
09/01/2020	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
05/22/2012	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063076s025lbl.pdf
11/30/2011	SUPPL-18	Labeling		Label is not available on this site.
07/25/2005	SUPPL-10	Labeling		Label is not available on this site.
10/04/2002	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/01/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/2001	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
12/09/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/18/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/25/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 063076

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2012	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063076s025lbl.pdf

Therapeutic Equivalents for ANDA 063076

VANCOMYCIN HYDROCHLORIDE

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	EUGIA PHARMA
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	205694	GLAND PHARMA LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215821	HAINAN POLY
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	215196	MEITHEAL
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	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	EUGIA PHARMA
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	205694	GLAND PHARMA LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215821	HAINAN POLY
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	063076	HOSPIRA
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	215196	MEITHEAL
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	204125	XELLIA PHARMS APS

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