Application 050542
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | TABLET, CHEWABLE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | TABLET, CHEWABLE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78387 | SUPPL | 2024-05-03 |
| 78359 | SUPPL | 2024-05-02 |
| 72561 | SUPPL | 2022-11-04 |
| 72553 | SUPPL | 2022-11-03 |
| 30069 | SUPPL | 2015-12-08 |
| 17865 | SUPPL | 2015-12-08 |
| 38972 | SUPPL | 2015-09-29 |
| 30068 | SUPPL | 2015-09-28 |
| 38971 | SUPPL | 2011-11-21 |
| 30067 | SUPPL | 2011-11-21 |
| 30066 | SUPPL | 2011-11-21 |
| 17864 | SUPPL | 2011-11-21 |
| 17863 | SUPPL | 2011-11-21 |
| 7801 | SUPPL | 2011-11-21 |
| 7799 | SUPPL | 2008-06-13 |
| 17862 | SUPPL | 2008-06-12 |
| 7800 | SUPPL | 2008-04-02 |
| 38970 | SUPPL | 2008-04-01 |
| 22160 | SUPPL | 2004-09-09 |
| 22159 | SUPPL | 2004-09-09 |
| 30065 | SUPPL | 2004-07-21 |
| 30063 | SUPPL | 2004-05-27 |
| 7798 | SUPPL | 2003-12-22 |
| 30064 | SUPPL | 2003-06-08 |
| 42649 | SUPPL | 1998-02-27 |
| 42648 | SUPPL | 1998-02-27 |
| 22158 | SUPPL | 1998-02-27 |