Application 050824
- Type
- NDA
- Sponsor
- CUMBERLAND PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN | AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66220-422 | Omeclamox-Pak | omeprazole, clarithromycin, amoxicillin | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-422 | Omeclamox-Pak | omeprazole, clarithromycin, amoxicillin | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-422 | Omeclamox-Pak | omeprazole, clarithromycin, amoxicillin | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-422 | Omeclamox-Pak | omeprazole, clarithromycin, amoxicillin | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-422 | Omeclamox-Pak | omeprazole, clarithromycin, amoxicillin | Cumberland Pharmaceuticals Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 78386 | SUPPL | 2024-05-03 |
| 78357 | SUPPL | 2024-05-02 |
| 75127 | SUPPL | 2023-08-18 |
| 75126 | SUPPL | 2023-08-18 |
| 75103 | SUPPL | 2023-08-17 |
| 75102 | SUPPL | 2023-08-17 |
| 70485 | SUPPL | 2022-03-11 |
| 70430 | SUPPL | 2022-03-07 |
| 65426 | SUPPL | 2020-12-01 |
| 65366 | SUPPL | 2020-11-30 |
| 61623 | SUPPL | 2020-01-23 |
| 61618 | SUPPL | 2020-01-22 |
| 53933 | ORIG | 2018-05-01 |
| 52434 | APPL | 2018-02-06 |
| 45725 | SUPPL | 2016-10-31 |
| 45649 | SUPPL | 2016-10-26 |
| 39393 | SUPPL | 2015-01-09 |
| 8345 | SUPPL | 2014-12-31 |
| 24352 | ORIG | 2011-12-08 |
| 22252 | ORIG | 2011-12-08 |
| 8344 | ORIG | 2011-02-14 |
| 18301 | ORIG | 2011-02-09 |