Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022108
Company: VALEANT PHARMS NORTH
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
05/04/2017 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide 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-Package Insert, Labeling-Medication Guide 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
05/04/2017 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf
05/04/2017 SUPPL-14 Labeling-Medication Guide 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s009lbl.pdf
12/30/2014 SUPPL-9 Labeling-Medication Guide 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

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