Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091072
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 3MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | EQ 6MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/16/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/17/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/21/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |