Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091520
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/09/2011 | 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 |
|---|---|---|---|---|---|
| 05/07/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/25/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/25/2017 | SUPPL-7 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 04/23/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |