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COPEGUS از شرکت ROCHE

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COPEGUS از شرکت ROCHE

New Drug Application (NDA): 021511

Company: ROCHE

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COPEGUS RIBAVIRIN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued

None

Yes No
COPEGUS RIBAVIRIN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued

None

Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/03/2002 ORIG-1 Approval

Type 3 – New Dosage Form

PRIORITY

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21511_Copegus_lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21511ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-511_Copegus.cfm

Supplements
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)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021511Orig1s029ltr.pdf

03/04/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-26 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021511s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021511Orig1s026ltr.pdf

05/09/2011 SUPPL-24 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s024ltr.pdf

08/22/2011 SUPPL-23 Efficacy-Pediatric, REMS-Modified

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf

08/09/2011 SUPPL-22 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf

12/21/2010 SUPPL-21 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s021ltr.pdf

10/08/2010 SUPPL-20 REMS-Modified, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s020lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s020ltr.pdf

06/09/2010 SUPPL-19 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s019ltr.pdf

03/03/2010 SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s018ltr.pdf

04/15/2009 SUPPL-17 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021511s016,021511s017ltr.pdf

04/15/2009 SUPPL-16 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021511s016,021511s017ltr.pdf

04/17/2008 SUPPL-15 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021511s015ltr.pdf

06/19/2007 SUPPL-14 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021511s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021511s014ltr.pdf

11/23/2005 SUPPL-12 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s012ltr.pdf

06/21/2005 SUPPL-8 Manufacturing (CMC)-Formulation

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s008ltr.pdf

08/16/2005 SUPPL-7 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s007ltr.pdf

08/22/2005 SUPPL-6 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006ltr.pdf

02/25/2005 SUPPL-5 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s005ltr.pdf

05/05/2004 SUPPL-2 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21511slr002_copegus_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21511slr002ltr.pdf

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
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