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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204384
Company: JANSSEN THERAP

Medication Guide

Summary Review

Products on NDA 204384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SIRTURO	BEDAQUILINE FUMARATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
SIRTURO	BEDAQUILINE FUMARATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204384

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204384Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2024	SUPPL-19	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204384s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204384Orig1s019ltr.pdf
10/12/2023	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204384s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204384Orig1s017ltr.pdf
09/23/2021	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204384s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204384Orig1s016ltr.pdf
01/06/2020	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204384s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204384Orig1s014ltr.pdf
05/27/2020	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204384s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204384Orig1s013ltr.pdf
08/15/2019	SUPPL-12	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204384Orig1s012ltr.pdf
12/03/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204384s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204384Orig1s011ltr.pdf
08/09/2019	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204384s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204384Orig1s010ltr.pdf
02/10/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/09/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s006ltr.pdf
05/14/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s005ltr.pdf
10/17/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204384s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204384Orig1s004ltr.pdf
08/04/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/28/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204384s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204384Orig1s002ltr.pdf
03/19/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204384

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2024	SUPPL-19	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204384s019lbl.pdf
10/12/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204384s017lbl.pdf
10/12/2023	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204384s017lbl.pdf
09/23/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204384s016lbl.pdf
05/27/2020	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204384s013lbl.pdf
01/06/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204384s014lbl.pdf
12/03/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204384s011lbl.pdf
08/09/2019	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204384s010lbl.pdf
12/09/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s006lbl.pdf
05/14/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s005lbl.pdf
10/17/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204384s004lbl.pdf
08/28/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204384s002lbl.pdf
12/28/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf

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