Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | COPEGUS | RIBAVIRIN |
| 002 | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | COPEGUS | RIBAVIRIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-12-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-05-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2005-02-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 2005-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2005-08-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2005-06-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 2005-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2007-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2008-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2009-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2009-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2010-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2010-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2010-10-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2010-12-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2011-08-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2011-08-22 | PRIORITY |
| REMS; REMS | SUPPL | 24 | AP | 2011-05-09 | N/A |
| LABELING; Labeling | SUPPL | 26 | AP | 2013-02-06 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2014-03-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 2015-08-11 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 0 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 7 |
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 21511
[companyName] => ROCHE
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2015\/021511s029lbl.pdf#page=27"]
[products] => [{"drugName":"COPEGUS","activeIngredients":"RIBAVIRIN","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COPEGUS","activeIngredients":"RIBAVIRIN","strength":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/11\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021511s029lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021511s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2011","submission":"SUPPL-23","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021511s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2011","submission":"SUPPL-23","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021511s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2011","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021511s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2010","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2010","submission":"SUPPL-20","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2010","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2010","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2010","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021511s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2005","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2005","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2005","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2004","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21511slr002_copegus_lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21511_Copegus_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"COPEGUS","submission":"RIBAVIRIN","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COPEGUS","submission":"RIBAVIRIN","actionType":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2015-08-11
)
)