Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077415
Company: IMPAX LABS
Company: IMPAX LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/15/2006 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/07/2020 | SUPPL-36 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/26/2017 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/26/2017 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2017 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2014 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2012 | SUPPL-18 | Labeling-Package Insert |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf |
| 08/30/2011 | SUPPL-17 | Labeling-Package Insert |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf |
| 05/13/2010 | SUPPL-15 | REMS-Proposal |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2009 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/26/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/26/2008 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/17/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/17/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |