Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210169
Company: MSN

Products on ANDA 210169

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210169

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210169

VALGANCICLOVIR HYDROCHLORIDE

FOR SOLUTION;ORAL; 50MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALCYTE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	Yes	AB	022257	CHEPLAPHARM
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	205220	ACTAVIS LABS FL INC
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	212890	AJANTA PHARMA LTD
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	216317	APPCO
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	215124	AUROBINDO PHARMA
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	213306	GRANULES
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	211475	HETERO LABS LTD V
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION;ORAL	Prescription	No	AB	210169	MSN