Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217489
Company: HIKMA

Products on ANDA 217489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217489

VANCOMYCIN HYDROCHLORIDE

POWDER;INTRAVENOUS; EQ 1.25GM 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 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217401	EUGIA PHARMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217489	HIKMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD

POWDER;INTRAVENOUS; EQ 1.5GM 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 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217401	EUGIA PHARMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217489	HIKMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD