Application 050597
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUGMENTIN '125' | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET, CHEWABLE;ORAL | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AUGMENTIN '250' | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET, CHEWABLE;ORAL | 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78372 | SUPPL | 2024-05-02 |
| 78365 | SUPPL | 2024-05-02 |
| 71947 | SUPPL | 2022-08-29 |
| 71929 | SUPPL | 2022-08-26 |
| 57673 | ORIG | 2019-02-15 |
| 30148 | SUPPL | 2013-01-24 |
| 7870 | SUPPL | 2013-01-24 |
| 39027 | SUPPL | 2013-01-23 |
| 39026 | SUPPL | 2013-01-23 |
| 39025 | SUPPL | 2011-10-18 |
| 30147 | SUPPL | 2011-10-04 |
| 30146 | SUPPL | 2008-12-11 |
| 17916 | SUPPL | 2008-12-08 |
| 7869 | SUPPL | 2008-04-02 |
| 39024 | SUPPL | 2008-03-27 |
| 7868 | SUPPL | 2004-08-12 |
| 30145 | SUPPL | 2004-06-07 |
| 30143 | SUPPL | 2004-05-27 |
| 30144 | SUPPL | 2003-06-08 |