Application 050605
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66686 | SUPPL | 2021-03-09 |
| 66662 | SUPPL | 2021-03-09 |
| 58451 | SUPPL | 2019-04-26 |
| 58434 | SUPPL | 2019-04-26 |
| 50086 | SUPPL | 2017-10-18 |
| 50071 | SUPPL | 2017-10-17 |
| 45977 | SUPPL | 2016-12-01 |
| 45950 | SUPPL | 2016-11-23 |
| 30156 | SUPPL | 2015-08-28 |
| 17922 | SUPPL | 2015-08-27 |
| 30155 | SUPPL | 2015-07-07 |
| 39033 | SUPPL | 2015-07-01 |
| 30154 | SUPPL | 2014-09-23 |
| 30153 | SUPPL | 2014-09-23 |
| 39032 | SUPPL | 2014-09-22 |
| 39031 | SUPPL | 2014-09-22 |
| 30152 | SUPPL | 2007-07-27 |
| 17921 | SUPPL | 2007-07-24 |
| 30151 | SUPPL | 2004-06-07 |
| 17920 | SUPPL | 2004-06-07 |
| 7876 | SUPPL | 2002-07-24 |
| 17919 | SUPPL | 2002-04-11 |
| 7875 | SUPPL | 2002-04-11 |
| 17918 | SUPPL | 2002-03-29 |
| 7874 | SUPPL | 2002-03-29 |
| 30150 | SUPPL | 1999-08-24 |
| 22166 | SUPPL | 1999-08-24 |