Application 214752
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION; OPHTHALMIC | 1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60219-1748 | Atropine | Atropine Sulfate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1749 | Atropine | atropine sulfate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1750 | Atropine | atropine sulfate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69862 | ORIG | 2022-01-12 |