Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021511
Company: ROCHE

• Medication Guide

• Release Letter

• Release 2 Letter

Products on NDA 21511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COPEGUS	RIBAVIRIN	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
COPEGUS	RIBAVIRIN	400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 021511

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2015	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf
02/06/2013	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021511s026lbl.pdf
08/22/2011	SUPPL-23	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf
08/22/2011	SUPPL-23	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf
08/09/2011	SUPPL-22	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s022lbl.pdf
12/21/2010	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s021lbl.pdf
10/08/2010	SUPPL-20	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s020lbl.pdf
10/08/2010	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s020lbl.pdf
06/09/2010	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s019lbl.pdf
03/03/2010	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s018lbl.pdf
06/19/2007	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021511s014lbl.pdf
11/23/2005	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s012lbl.pdf
08/22/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s006lbl.pdf
08/16/2005	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s007lbl.pdf
02/25/2005	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s005lbl.pdf
05/05/2004	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21511slr002_copegus_lbl.pdf
12/03/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21511_Copegus_lbl.pdf