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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215338
Company: AMNEAL

Products on ANDA 215338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215338

VANCOMYCIN HYDROCHLORIDE

FOR SOLUTION;ORAL; EQ 250MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	061667	ANI PHARMS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	215338	AMNEAL

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