Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091596
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/02/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |