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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200063
Company: NALPROPION

Medication Guide

Summary Review

Products on NDA 200063

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200063

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
05/07/2024	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200063s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200063Orig1s022ltr.pdf
11/30/2023	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200063s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200063Orig1s021ltr.pdf
04/14/2021	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200063Orig1s020ltr.pdf
08/04/2020	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200063Orig1s015ltr.pdf
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.

Labels for NDA 200063

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2024	SUPPL-22	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200063s022lbl.pdf
05/07/2024	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200063s022lbl.pdf
11/30/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200063s021lbl.pdf
11/30/2023	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200063s021lbl.pdf
04/14/2021	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf
04/14/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf
08/04/2020	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf
08/04/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf
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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