Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022108
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APLENZIN | BUPROPION HYDROBROMIDE | 174MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
APLENZIN | BUPROPION HYDROBROMIDE | 348MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
APLENZIN | BUPROPION HYDROBROMIDE | 522MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/23/2008 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022108s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/07/2024 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022108s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022108Orig1s023;021515Orig1s046ltr.pdf | |
03/04/2022 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022108s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021515Orig1s044; 022108Orig1s022Corrected_ltr.pdf | |
07/08/2021 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022108s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021515Orig1s043; 022108Orig1s021ltr.pdf | |
05/01/2020 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022108s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022108Orig1s020ltr.pdf | |
05/04/2017 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021515Orig1s036,022108Orig1s014ltr.pdf | |
08/30/2016 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022108s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022108Orig1s012ltr.pdf | |
07/09/2014 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022108Orig1s011ltr.pdf | |
12/30/2014 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf | |
08/15/2012 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022108s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022108Orig1s007ltr.pdf | |
07/26/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf | |
07/26/2011 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf | |
04/29/2011 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s003ltr.pdf | |
04/29/2011 | SUPPL-2 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/07/2024 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022108s023lbl.pdf | |
05/07/2024 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022108s023lbl.pdf | |
03/04/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022108s022lbl.pdf | |
07/08/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022108s021lbl.pdf | |
05/01/2020 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022108s020lbl.pdf | |
05/04/2017 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf | |
05/04/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf | |
08/30/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022108s012lbl.pdf | |
12/30/2014 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s009lbl.pdf | |
12/30/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s009lbl.pdf | |
07/09/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s011lbl.pdf | |
08/15/2012 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022108s007lbl.pdf | |
07/26/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf | |
07/26/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf | |
04/29/2011 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s003lbl.pdf | |
04/23/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022108lbl.pdf |