Application 050760
- Type
- NDA
- Sponsor
- NEOPHARMA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application
Documents
| Document | Submission type | Date |
|---|---|---|
| 78361 | SUPPL | 2024-05-02 |
| 78349 | SUPPL | 2024-05-02 |
| 72563 | SUPPL | 2022-11-04 |
| 72555 | SUPPL | 2022-11-03 |
| 39298 | SUPPL | 2015-12-08 |
| 8233 | SUPPL | 2015-12-08 |
| 18205 | SUPPL | 2015-09-29 |
| 8232 | SUPPL | 2015-09-28 |
| 39297 | SUPPL | 2011-11-21 |
| 39296 | SUPPL | 2011-11-21 |
| 30498 | SUPPL | 2011-11-21 |
| 30497 | SUPPL | 2011-11-21 |
| 18204 | SUPPL | 2011-11-21 |
| 8231 | SUPPL | 2011-11-21 |
| 8229 | SUPPL | 2008-06-13 |
| 18203 | SUPPL | 2008-06-12 |
| 8230 | SUPPL | 2008-04-02 |
| 39295 | SUPPL | 2008-04-01 |
| 30496 | SUPPL | 2006-01-30 |
| 39294 | SUPPL | 2006-01-27 |
| 42724 | ORIG | 2005-07-11 |
| 42725 | SUPPL | 2004-09-09 |
| 30495 | SUPPL | 2004-07-21 |
| 30494 | SUPPL | 2003-12-22 |
| 30493 | SUPPL | 2003-06-08 |
| 30492 | ORIG | 1999-04-15 |
| 18202 | ORIG | 1999-04-15 |