Drugs@FDA: FDA-Approved Drugs

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

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