Application 022348
- Type
- NDA
- Sponsor
- CUMBERLAND PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CALDOLOR | IBUPROFEN | SOLUTION;INTRAVENOUS | 400MG/4ML (100MG/ML) | No | No |
| 002 | CALDOLOR | IBUPROFEN | SOLUTION;INTRAVENOUS | 800MG/8ML (100MG/ML) | Yes | Yes |
| 003 | CALDOLOR | IBUPROFEN | SOLUTION;INTRAVENOUS | 800MG/200ML (4MG/ML) | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66220-284 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-284 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-284 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-287 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-287 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-287 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-287 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-287 | Caldolor | ibuprofen | Cumberland Pharmaceuticals Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 84846 | SUPPL | 2026-01-28 |
| 84834 | SUPPL | 2026-01-26 |
| 80390 | SUPPL | 2024-11-25 |
| 80308 | SUPPL | 2024-11-22 |
| 74232 | SUPPL | 2023-05-12 |
| 72828 | SUPPL | 2022-12-08 |
| 72814 | SUPPL | 2022-12-07 |
| 69386 | SUPPL | 2021-11-23 |
| 69364 | SUPPL | 2021-11-22 |
| 67333 | SUPPL | 2021-05-03 |
| 67274 | SUPPL | 2021-04-30 |
| 59424 | SUPPL | 2019-07-23 |
| 59418 | SUPPL | 2019-07-23 |
| 38607 | SUPPL | 2016-05-11 |
| 29633 | SUPPL | 2016-05-11 |
| 17280 | SUPPL | 2015-11-25 |
| 7278 | SUPPL | 2015-11-23 |
| 7277 | SUPPL | 2015-01-28 |
| 42496 | ORIG | 2010-03-11 |
| 24286 | ORIG | 2010-03-11 |
| 38606 | ORIG | 2009-06-22 |
| 29632 | ORIG | 2009-06-17 |
| 51171 | SUPPL | 1900-01-01 |
| 51170 | SUPPL | 1900-01-01 |
| 51169 | SUPPL | 1900-01-01 |
| 51168 | SUPPL | 1900-01-01 |