Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201950
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG 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 |
---|---|---|---|---|---|---|---|
09/12/2013 | 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 |
---|---|---|---|---|---|
12/17/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |