Application 212780
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMINOCAPROIC ACID | AMINOCAPROIC ACID | SYRUP;ORAL | 1.25GM/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60687-529 | Aminocaproic acid | Aminocaproic acid | American Health Packaging | ANDA | Current |
| 69238-1596 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1596 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1596 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60207 | ORIG | 2019-10-03 |