Application 072547
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETYLCYSTEINE | ACETYLCYSTEINE | SOLUTION;INHALATION, ORAL | 20% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0517-7604 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7604 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7604 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7610 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7610 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7610 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7630 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7630 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 0517-7630 | Acetylcysteine | acetylcysteine | American Regent, Inc. | ANDA | Current |
| 55154-5731 | Acetylcysteine | Acetylcysteine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5731 | Acetylcysteine | Acetylcysteine | Cardinal Health | ANDA | Current |
| 55154-5731 | Acetylcysteine | Acetylcysteine | Cardinal Health | ANDA | Current |
| 55154-5731 | Acetylcysteine | Acetylcysteine | Cardinal Health | ANDA | Current |