Application 050726
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUGMENTIN '200' | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET, CHEWABLE;ORAL | 200MG;EQ 28.5MG BASE | Yes | No |
| 002 | AUGMENTIN '400' | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET, CHEWABLE;ORAL | 400MG;EQ 57MG BASE | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78375 | SUPPL | 2024-05-02 |
| 78368 | SUPPL | 2024-05-02 |
| 71950 | SUPPL | 2022-08-29 |
| 71932 | SUPPL | 2022-08-26 |
| 30393 | SUPPL | 2013-01-24 |
| 8132 | SUPPL | 2013-01-24 |
| 18137 | SUPPL | 2013-01-23 |
| 18136 | SUPPL | 2013-01-23 |
| 18135 | SUPPL | 2011-10-18 |
| 8131 | SUPPL | 2011-10-04 |
| 8130 | SUPPL | 2008-12-11 |
| 18133 | SUPPL | 2008-12-08 |
| 30392 | SUPPL | 2008-04-02 |
| 18134 | SUPPL | 2008-03-27 |
| 8129 | SUPPL | 2004-08-12 |
| 8128 | SUPPL | 2004-06-07 |
| 30390 | SUPPL | 2004-05-27 |
| 30391 | SUPPL | 2003-06-08 |