Application 050672
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTIN | CEFUROXIME AXETIL | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | Yes | No |
| 002 | CEFTIN | CEFUROXIME AXETIL | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66687 | SUPPL | 2021-03-09 |
| 66663 | SUPPL | 2021-03-09 |
| 58435 | SUPPL | 2019-04-26 |
| 50085 | SUPPL | 2017-10-18 |
| 50072 | SUPPL | 2017-10-17 |
| 45976 | SUPPL | 2016-12-01 |
| 45951 | SUPPL | 2016-11-23 |
| 30257 | SUPPL | 2015-08-28 |
| 18002 | SUPPL | 2015-08-27 |
| 30256 | SUPPL | 2015-07-07 |
| 39091 | SUPPL | 2015-07-01 |
| 30255 | SUPPL | 2014-09-23 |
| 30254 | SUPPL | 2014-09-23 |
| 39090 | SUPPL | 2014-09-22 |
| 39089 | SUPPL | 2014-09-22 |
| 39088 | SUPPL | 2007-08-02 |
| 7968 | SUPPL | 2007-08-02 |
| 39087 | SUPPL | 2004-06-07 |
| 30253 | SUPPL | 2004-06-07 |
| 30252 | SUPPL | 2002-04-11 |
| 18001 | SUPPL | 2002-04-11 |
| 18000 | SUPPL | 2002-03-29 |
| 7967 | SUPPL | 2002-03-29 |
| 30251 | SUPPL | 1999-08-24 |
| 22176 | SUPPL | 1999-08-24 |