Application 204674
- Type
- ANDA
- Sponsor
- ALVOGEN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETYLCYSTEINE | ACETYLCYSTEINE | SOLUTION;INHALATION, ORAL | 10% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63323-691 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-691 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-691 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-693 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-693 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-693 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-695 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-695 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-695 | Acetylcysteine | ACETYLCYSTEINE | Fresenius Kabi USA, LLC | ANDA | Current |