Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202012
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPROSARTAN MESYLATE | EPROSARTAN MESYLATE | EQ 400MG BASE | TABLET;ORAL | Discontinued | None | No | No |
EPROSARTAN MESYLATE | EPROSARTAN MESYLATE | EQ 600MG BASE | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
11/16/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202012s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
09/20/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |