Application 202755
- Type
- ANDA
- Sponsor
- VIRTUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRANEXAMIC ACID | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69543-376 | Tranexamic Acid | Tranexamic Acid | Virtus Pharmaceuticals, LLC | ANDA | Current |
| 69543-376 | Tranexamic Acid | Tranexamic Acid | Virtus Pharmaceuticals, LLC | ANDA | Current |
| 69543-376 | Tranexamic Acid | Tranexamic Acid | Virtus Pharmaceuticals, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10100 | ORIG | 2016-03-02 |