Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090900
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | EQ 8MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | EQ 16MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | EQ 24MG BASE | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/24/2011 | 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 |
|---|---|---|---|---|---|
| 10/25/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/09/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/09/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |