Application 204797
- Type
- ANDA
- Sponsor
- EXELA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETYLCYSTEINE | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51754-0104 | Acetylcysteine | Acetylcysteine Injection | Exela Pharma Sciences, LLC | ANDA | Current |