Application 018972
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CORDARONE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56054 | SUPPL | 2018-10-22 |
| 56007 | SUPPL | 2018-10-18 |
| 56006 | SUPPL | 2018-10-18 |
| 47978 | SUPPL | 2017-04-12 |
| 47918 | SUPPL | 2017-04-10 |
| 47917 | SUPPL | 2017-04-10 |
| 45988 | SUPPL | 2016-12-01 |
| 45955 | SUPPL | 2016-11-23 |
| 11399 | SUPPL | 2016-04-29 |
| 1175 | SUPPL | 2016-04-26 |
| 11397 | SUPPL | 2015-04-01 |
| 16154 | SUPPL | 2015-03-31 |
| 11398 | SUPPL | 2015-01-08 |
| 1174 | SUPPL | 2014-12-24 |
| 33677 | SUPPL | 2014-01-23 |
| 1173 | SUPPL | 2014-01-23 |
| 16153 | SUPPL | 2011-11-16 |
| 33676 | SUPPL | 2011-11-14 |
| 1172 | SUPPL | 2010-12-15 |
| 11396 | SUPPL | 2010-12-13 |
| 1171 | SUPPL | 2010-01-07 |
| 11395 | SUPPL | 2009-11-23 |
| 16152 | SUPPL | 2009-11-12 |
| 11394 | SUPPL | 2009-04-28 |
| 11393 | SUPPL | 2009-04-28 |
| 16151 | SUPPL | 2009-04-24 |
| 1170 | SUPPL | 2009-04-24 |
| 1169 | SUPPL | 2008-10-21 |
| 1168 | SUPPL | 2007-11-19 |
| 1167 | SUPPL | 2007-10-04 |
| 16150 | SUPPL | 2007-04-09 |
| 1166 | SUPPL | 2006-09-25 |
| 16149 | SUPPL | 2006-09-18 |
| 16148 | SUPPL | 2005-08-31 |
| 44026 | ORIG | 2005-07-29 |
| 40839 | SUPPL | 2005-04-27 |
| 16147 | SUPPL | 2004-12-06 |
| 11392 | SUPPL | 2004-12-06 |
| 16146 | SUPPL | 2004-11-08 |
| 1165 | SUPPL | 2004-09-03 |
| 40834 | ORIG | 2004-08-26 |
| 1163 | SUPPL | 2004-06-01 |
| 1164 | SUPPL | 2004-05-27 |
| 1162 | SUPPL | 2004-05-27 |
| 16145 | SUPPL | 2003-05-30 |
| 16144 | SUPPL | 2003-05-29 |
| 40838 | SUPPL | 1999-10-08 |
| 20174 | SUPPL | 1999-10-08 |
| 40836 | SUPPL | 1999-01-05 |
| 20172 | SUPPL | 1999-01-05 |
| 16143 | SUPPL | 1999-01-05 |
| 1161 | SUPPL | 1999-01-05 |
| 40837 | SUPPL | 1998-06-15 |
| 40835 | SUPPL | 1998-06-15 |
| 20173 | SUPPL | 1998-06-15 |