Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077131
Company: SUN PHARM
Company: SUN PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 10/22/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077131s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |