Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202755
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 02/25/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202755Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2018 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |