Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022497
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORFIVO XL BUPROPION HYDROCHLORIDE 450MG 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
11/10/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022497s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022497s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497_forfivo_xl_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/04/2017 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022497Orig1s004ltr.pdf
08/30/2016 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf
07/17/2014 SUPPL-2 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022497Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2017 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf
05/04/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf
08/30/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf
08/30/2016 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf
07/17/2014 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf
11/10/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022497s000lbl.pdf

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