Application 050813
- Type
- NDA
- Sponsor
- PRAGMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOXATAG | AMOXICILLIN | TABLET, EXTENDED RELEASE;ORAL | 775MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69442-030 | MOXATAG | amoxicillin | Vernalis Therapeutics, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78380 | SUPPL | 2024-05-03 |
| 78356 | SUPPL | 2024-05-02 |
| 71098 | SUPPL | 2022-05-19 |
| 71092 | SUPPL | 2022-05-18 |
| 69822 | SUPPL | 2022-01-07 |
| 60809 | SUPPL | 2019-11-12 |
| 18294 | SUPPL | 2019-06-05 |
| 8334 | SUPPL | 2015-06-10 |
| 42751 | ORIG | 2010-03-26 |
| 24347 | ORIG | 2010-03-26 |
| 8333 | ORIG | 2008-01-25 |
| 39380 | ORIG | 2008-01-24 |
| 53173 | ORIG | 1900-01-01 |
| 53172 | ORIG | 1900-01-01 |
| 53171 | ORIG | 1900-01-01 |