Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206556
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 08/26/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/01/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2024 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/30/2020 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/12/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |