Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075764
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESNA | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75764ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075764.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-28 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/21/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |