Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200063
Company: NALPROPION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CONTRAVE BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE 90MG;8MG 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
09/10/2014 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200063Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200063Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200063Orig1s013ltr.pdf
05/04/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200063Orig1sS009ltr.pdf
03/10/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200063Orig1s006ltr.pdf
01/27/2017 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/06/2017 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/08/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/16/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf
05/04/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s009lbl.pdf
03/10/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s006lbl.pdf
09/10/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf

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