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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065397
Company: MYLAN LABS LTD

Products on ANDA 065397

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	No
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2008	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
06/04/2021	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
08/19/2020	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
08/19/2020	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
08/19/2020	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
08/19/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/19/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/19/2020	SUPPL-17	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/19/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/30/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/23/2009	SUPPL-2	Labeling		Label is not available on this site.
05/29/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065397

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

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	065401	EUROFARMA
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
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	204107	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	212332	SLATE RUN PHARMA

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