Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078484
Company: IMPAX LABS
Company: IMPAX LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 05/27/2009 | 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 |
|---|---|---|---|---|---|
| 06/28/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/28/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/06/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |