Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218130
Company: AUROBINDO PHARMA

Products on ANDA 218130

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	AA	No	No
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218130

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218130

VANCOMYCIN HYDROCHLORIDE

FOR SOLUTION;ORAL; EQ 25MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	Yes	AA	208910	AZURITY
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	No	AA	214913	ALKEM LABS LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	No	AA	218130	AUROBINDO PHARMA

FOR SOLUTION;ORAL; EQ 50MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	Yes	AA	208910	AZURITY
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	No	AA	214913	ALKEM LABS LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	No	AA	218130	AUROBINDO PHARMA