Application 212492
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMINOCAPROIC ACID | AMINOCAPROIC ACID | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7165 | Aminocaproic acid | Aminocaproic acid | Major Pharmaceuticals | ANDA | Current |
| 60219-1637 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1637 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1637 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1637 | Aminocaproic acid | Aminocaproic acid | Amneal Pharmaceuticals NY LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61122 | ORIG | 2019-12-03 |