Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076203
Company: CHARTWELL RX

• Medication Guide

• Exclusivity Letter

Products on ANDA 76203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIBASPHERE	RIBAVIRIN	200MG	CAPSULE;ORAL	Discontinued	None	No	No

Labels for ANDA 076203

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76203LBL_Ribasphere.pdf