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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216460
Company: RUBICON

Products on ANDA 216460

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALSARTAN	VALSARTAN	4MG/ML	SOLUTION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216460

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216460

VALSARTAN

SOLUTION;ORAL; 4MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALSARTAN	VALSARTAN	4MG/ML	SOLUTION;ORAL	Prescription	No	AB	214102	NOVITIUM PHARMA
VALSARTAN	VALSARTAN	4MG/ML	SOLUTION;ORAL	Prescription	No	AB	216460	RUBICON

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