Application 021539
- Type
- NDA
- Sponsor
- CUMBERLAND PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETADOTE | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0574-0805 | acetylcysteine | Acetylcysteine | Paddock Laboratories, LLC | NDA | Current |
| 0574-0805 | acetylcysteine | Acetylcysteine | Padagis US LLC | NDA | Current |
| 0574-0805 | acetylcysteine | Acetylcysteine | Paddock Laboratories, LLC | NDA | Current |
| 0574-0805 | acetylcysteine | Acetylcysteine | Paddock Laboratories, LLC. | NDA | Current |
| 0574-0815 | Acetylcysteine | acetylcysteine | Paddock Laboratories, LLC | NDA | Current |
| 0574-0815 | Acetylcysteine | acetylcysteine | Paddock Laboratories, LLC | NDA | Current |
| 0574-0815 | Acetylcysteine | acetylcysteine | Paddock Laboratories, LLC | NDA | Current |
| 66220-207 | ACETADOTE | Acetylcysteine | Cumberland Pharmaceutical | NDA | Current |
| 66220-207 | ACETADOTE | Acetylcysteine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-207 | ACETADOTE | Acetylcysteine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-207 | ACETADOTE | Acetylcysteine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-207 | ACETADOTE | Acetylcysteine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-207 | ACETADOTE | Acetylcysteine | Cumberland Pharmaceuticals Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 82934 | SUPPL | 2025-07-25 |
| 82918 | SUPPL | 2025-07-25 |
| 80442 | SUPPL | 2024-11-29 |
| 80436 | SUPPL | 2024-11-27 |
| 68797 | SUPPL | 2021-09-28 |
| 60762 | SUPPL | 2019-10-31 |
| 60749 | SUPPL | 2019-10-31 |
| 46987 | SUPPL | 2017-01-27 |
| 46959 | SUPPL | 2017-01-24 |
| 37182 | SUPPL | 2016-08-02 |
| 5682 | SUPPL | 2016-08-02 |
| 15726 | SUPPL | 2013-06-11 |
| 28061 | SUPPL | 2013-06-06 |
| 5681 | SUPPL | 2008-12-19 |
| 37181 | SUPPL | 2006-02-22 |
| 5680 | SUPPL | 2006-02-22 |
| 42205 | ORIG | 2004-10-18 |
| 37180 | SUPPL | 2004-05-04 |
| 15725 | SUPPL | 2004-05-04 |
| 28060 | SUPPL | 2004-05-03 |
| 28059 | SUPPL | 2004-04-29 |
| 15724 | ORIG | 2004-02-03 |
| 5679 | ORIG | 2004-02-02 |