Application 200644
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-963 | Acetylcysteine | Acetylcysteine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-963 | Acetylcysteine | Acetylcysteine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-963 | Acetylcysteine | Acetylcysteine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-963 | Acetylcysteine | Acetylcysteine | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43351 | ORIG | 2013-01-22 |