Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209139
Company: CARMEL BIOSCIENCES

Products on NDA 209139

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209139s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209139Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209139Orig1s000TOC.html

Labels for NDA 209139

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209139s000lbl.pdf

Therapeutic Equivalents for NDA 209139

PREXXARTAN

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREXXARTAN	VALSARTAN	4MG/ML	SOLUTION;ORAL	Prescription	Yes	AB	209139	CARMEL BIOSCIENCES
VALSARTAN	VALSARTAN	4MG/ML	SOLUTION;ORAL	Prescription	No	AB	214102	NOVITIUM PHARMA
VALSARTAN	VALSARTAN	4MG/ML	SOLUTION;ORAL	Prescription	No	AB	216460	RUBICON RESEARCH