Application 021511
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COPEGUS | RIBAVIRIN | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | COPEGUS | RIBAVIRIN | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46117 | SUPPL | 2016-12-09 |
| 37108 | SUPPL | 2015-08-12 |
| 5586 | SUPPL | 2015-08-12 |
| 37107 | SUPPL | 2013-02-08 |
| 27980 | SUPPL | 2013-02-08 |
| 27978 | SUPPL | 2011-08-26 |
| 37106 | SUPPL | 2011-08-24 |
| 27977 | SUPPL | 2011-08-11 |
| 15638 | SUPPL | 2011-08-11 |
| 27979 | SUPPL | 2011-05-11 |
| 37105 | SUPPL | 2010-12-22 |
| 27976 | SUPPL | 2010-12-22 |
| 27975 | SUPPL | 2010-10-13 |
| 15637 | SUPPL | 2010-10-12 |
| 37104 | SUPPL | 2010-06-24 |
| 5585 | SUPPL | 2010-06-15 |
| 27974 | SUPPL | 2010-03-08 |
| 37103 | SUPPL | 2010-03-05 |
| 27973 | SUPPL | 2009-05-07 |
| 5584 | SUPPL | 2009-05-07 |
| 27972 | SUPPL | 2008-04-22 |
| 5583 | SUPPL | 2007-07-05 |
| 37102 | SUPPL | 2007-06-27 |
| 37101 | SUPPL | 2005-11-30 |
| 27971 | SUPPL | 2005-11-30 |
| 24002 | SUPPL | 2005-11-01 |
| 24003 | SUPPL | 2005-09-22 |
| 15636 | SUPPL | 2005-08-24 |
| 5581 | SUPPL | 2005-08-24 |
| 37100 | SUPPL | 2005-08-19 |
| 27970 | SUPPL | 2005-08-19 |
| 5582 | SUPPL | 2005-06-23 |
| 27969 | SUPPL | 2005-03-03 |
| 15635 | SUPPL | 2005-03-03 |
| 21706 | ORIG | 2004-08-10 |
| 15634 | SUPPL | 2004-05-07 |
| 5580 | SUPPL | 2004-05-07 |
| 27968 | ORIG | 2002-12-03 |
| 15633 | ORIG | 2002-12-03 |
| 53396 | ORIG | 1900-01-01 |
| 53395 | ORIG | 1900-01-01 |
| 53394 | ORIG | 1900-01-01 |