Drugs@FDA: FDA-Approved Drugs
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, 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 |
|---|---|---|---|---|---|---|---|
| 12/03/2004 | 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 |
|---|---|---|---|---|---|
| 01/29/2025 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/08/2023 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/08/2023 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2010 | SUPPL-11 | REMS-Proposal |
Label is not available on this site. |
||
| 01/27/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/14/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |