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 076203

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2004	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76203LBL_Ribasphere.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76203ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2014	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/18/2013	SUPPL-16	REMS		Label is not available on this site.
02/28/2011	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/25/2008	SUPPL-14	Labeling		Label is not available on this site.
04/14/2008	SUPPL-13	Labeling		Label is not available on this site.
01/09/2007	SUPPL-11	Labeling		Label is not available on this site.
07/08/2005	SUPPL-8	Labeling		Label is not available on this site.
02/10/2005	SUPPL-7	Labeling		Label is not available on this site.

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