Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090942
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/14/2010 | 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 |
|---|---|---|---|---|---|
| 06/12/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/12/2017 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2013 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, REMS-Modified |
Label is not available on this site. |