Application 050785
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUGMENTIN XR | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 62.5MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-220 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Dr. Reddy's Laboratories Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80738 | SUPPL | 2024-12-26 |
| 80706 | SUPPL | 2024-12-26 |
| 78379 | SUPPL | 2024-05-03 |
| 78355 | SUPPL | 2024-05-02 |
| 72567 | SUPPL | 2022-11-04 |
| 72550 | SUPPL | 2022-11-03 |
| 18247 | SUPPL | 2014-04-08 |
| 8290 | SUPPL | 2014-04-07 |
| 18246 | SUPPL | 2013-12-03 |
| 8289 | SUPPL | 2013-11-29 |
| 8288 | SUPPL | 2011-08-31 |
| 39333 | SUPPL | 2011-08-30 |
| 39334 | SUPPL | 2010-09-10 |
| 18245 | SUPPL | 2010-09-10 |
| 30542 | SUPPL | 2010-09-09 |
| 18244 | SUPPL | 2009-01-02 |
| 8287 | SUPPL | 2008-12-19 |
| 30541 | SUPPL | 2008-04-22 |
| 30540 | SUPPL | 2005-06-21 |
| 18243 | SUPPL | 2005-06-21 |
| 8286 | SUPPL | 2004-09-17 |
| 8285 | SUPPL | 2004-05-26 |
| 42737 | ORIG | 2003-07-06 |
| 30539 | SUPPL | 2003-06-08 |
| 8284 | SUPPL | 2003-06-08 |
| 30538 | ORIG | 2002-09-25 |
| 18242 | ORIG | 2002-09-25 |
| 53175 | ORIG | 1900-01-01 |
| 53174 | ORIG | 1900-01-01 |