Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214102
Company: NOVITIUM PHARMA

Products on ANDA 214102

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214102Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214102

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