Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021511
Company: ROCHE
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| COPEGUS | RIBAVIRIN | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| COPEGUS | RIBAVIRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
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 |