Application 215342
- Type
- ANDA
- Sponsor
- AMNEAL EU LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 0.5MG/5ML (0.1MG/ML) | No | No |
| 002 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 1MG/10ML (0.1MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70121-1705 | atropine sulfate | atropine sulfate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 70121-1705 | atropine sulfate | atropine sulfate | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69666 | ORIG | 2021-12-20 |