Application 050754
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50436-4543 | AMOXICILLIN | amoxicillin | Unit Dose Services | NDA | Current |
| 61919-017 | AMOXICILLIN | AMOXICILLIN | Direct Rx | NDA | Current |
| 63187-013 | AMOXICILLIN | amoxicillin | Proficient Rx LP | NDA | Current |
| 63187-013 | AMOXICILLIN | amoxicillin | Proficient Rx LP | NDA | Current |
| 64205-219 | AMOXICILLIN | amoxicillin | ReadyMeds | NDA | Current |
| 64205-224 | AMOXICILLIN | amoxicillin | ReadyMeds | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78360 | SUPPL | 2024-05-02 |
| 78348 | SUPPL | 2024-05-01 |
| 72562 | SUPPL | 2022-11-04 |
| 72554 | SUPPL | 2022-11-03 |
| 39258 | SUPPL | 2015-12-08 |
| 8195 | SUPPL | 2015-12-08 |
| 39257 | SUPPL | 2015-09-29 |
| 30454 | SUPPL | 2015-09-28 |
| 39256 | SUPPL | 2011-11-21 |
| 30453 | SUPPL | 2011-11-21 |
| 18182 | SUPPL | 2011-11-21 |
| 18181 | SUPPL | 2011-11-21 |
| 8194 | SUPPL | 2011-11-21 |
| 8193 | SUPPL | 2011-11-21 |
| 8191 | SUPPL | 2008-06-13 |
| 18180 | SUPPL | 2008-06-12 |
| 8192 | SUPPL | 2008-04-02 |
| 39255 | SUPPL | 2008-04-01 |
| 42717 | SUPPL | 2004-09-09 |
| 42716 | SUPPL | 2004-09-09 |
| 30452 | SUPPL | 2004-07-21 |
| 22220 | ORIG | 2004-05-27 |
| 8188 | SUPPL | 2004-05-27 |
| 8190 | SUPPL | 2003-12-22 |
| 8189 | SUPPL | 2003-06-08 |
| 30451 | ORIG | 1998-07-10 |