Application 050658
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIMENTIN IN PLASTIC CONTAINER | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/100ML;EQ 3GM BASE/100ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 17981 | SUPPL | 2014-06-17 |
| 7943 | SUPPL | 2014-06-17 |
| 30232 | SUPPL | 2013-10-01 |
| 17980 | SUPPL | 2013-10-01 |
| 30231 | SUPPL | 2012-10-09 |
| 17979 | SUPPL | 2012-10-05 |
| 17978 | SUPPL | 2011-06-14 |
| 7942 | SUPPL | 2011-06-13 |
| 7941 | SUPPL | 2010-12-28 |
| 17977 | SUPPL | 2010-12-26 |
| 7940 | SUPPL | 2008-12-19 |
| 17976 | SUPPL | 2008-06-05 |
| 30230 | SUPPL | 2008-04-22 |
| 30229 | SUPPL | 2007-03-23 |
| 17975 | SUPPL | 2007-03-16 |
| 7939 | SUPPL | 2004-12-02 |
| 7938 | SUPPL | 2002-03-18 |