Application 050698
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BIAXIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 125MG/5ML | Yes | No |
| 002 | BIAXIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 250MG/5ML | Yes | No |
| 003 | BIAXIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 187MG/5ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60048 | SUPPL | 2019-09-19 |
| 60038 | SUPPL | 2019-09-19 |
| 56941 | SUPPL | 2018-12-31 |
| 56893 | SUPPL | 2018-12-20 |
| 56767 | SUPPL | 2018-12-18 |
| 56612 | SUPPL | 2018-11-30 |
| 48704 | SUPPL | 2017-06-12 |
| 48692 | SUPPL | 2017-06-12 |
| 18040 | SUPPL | 2016-06-01 |
| 30299 | SUPPL | 2016-05-31 |
| 18041 | SUPPL | 2015-10-29 |
| 30301 | SUPPL | 2015-10-28 |
| 39134 | SUPPL | 2015-01-12 |
| 8033 | SUPPL | 2015-01-09 |
| 39133 | SUPPL | 2014-08-07 |
| 30300 | SUPPL | 2014-07-28 |
| 30298 | SUPPL | 2013-09-11 |
| 8032 | SUPPL | 2013-09-11 |
| 18039 | SUPPL | 2013-09-09 |
| 18038 | SUPPL | 2013-09-09 |
| 18037 | SUPPL | 2012-07-10 |
| 8030 | SUPPL | 2012-07-10 |
| 30297 | SUPPL | 2012-06-05 |
| 30296 | SUPPL | 2012-05-09 |
| 8031 | SUPPL | 2012-05-09 |
| 39132 | SUPPL | 2012-05-07 |
| 18036 | SUPPL | 2012-05-07 |
| 39131 | SUPPL | 2011-05-31 |
| 39130 | SUPPL | 2011-05-31 |
| 30295 | SUPPL | 2011-05-31 |
| 8029 | SUPPL | 2011-05-31 |
| 8028 | SUPPL | 2009-11-20 |
| 39129 | SUPPL | 2009-09-22 |
| 8027 | SUPPL | 2008-05-29 |
| 30294 | SUPPL | 2008-01-09 |
| 18035 | SUPPL | 2007-12-27 |
| 44204 | ORIG | 2006-09-25 |
| 8026 | SUPPL | 2006-07-13 |
| 8025 | SUPPL | 2005-10-20 |
| 18034 | SUPPL | 2005-10-10 |
| 8024 | SUPPL | 2004-07-21 |
| 8023 | SUPPL | 2002-05-24 |