Application 050761
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | TABLET, CHEWABLE;ORAL | 200MG | No | No |
| 002 | AMOXIL | AMOXICILLIN | TABLET, CHEWABLE;ORAL | 400MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78362 | SUPPL | 2024-05-02 |
| 78350 | SUPPL | 2024-05-02 |
| 72566 | SUPPL | 2022-11-04 |
| 72564 | SUPPL | 2022-11-04 |
| 30501 | SUPPL | 2015-12-08 |
| 18212 | SUPPL | 2015-12-08 |
| 18211 | SUPPL | 2015-09-29 |
| 8242 | SUPPL | 2015-09-28 |
| 18210 | SUPPL | 2011-11-21 |
| 18209 | SUPPL | 2011-11-21 |
| 18208 | SUPPL | 2011-11-21 |
| 8241 | SUPPL | 2011-11-21 |
| 8240 | SUPPL | 2011-11-21 |
| 8239 | SUPPL | 2011-11-21 |
| 30499 | SUPPL | 2008-06-13 |
| 39300 | SUPPL | 2008-06-12 |
| 30500 | SUPPL | 2008-04-02 |
| 18207 | SUPPL | 2008-04-01 |
| 8238 | SUPPL | 2006-01-30 |
| 18206 | SUPPL | 2006-01-27 |
| 42726 | ORIG | 2005-08-02 |
| 42727 | SUPPL | 2004-09-09 |
| 8237 | SUPPL | 2004-07-21 |
| 39299 | ORIG | 2004-05-27 |
| 8234 | ORIG | 2004-05-27 |
| 8236 | SUPPL | 2003-12-22 |
| 8235 | SUPPL | 2003-06-08 |