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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022108
Company: BAUSCH

Medication Guide

Summary Review

Products on NDA 022108

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022108

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
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

Labels for NDA 022108

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

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