Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202611
Company: APGDI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYRBETRIQ MIRABEGRON 25MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
MYRBETRIQ MIRABEGRON 50MG 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
06/28/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202611s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202611Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202611Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202611s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202611Orig1s012ltr.pdf
04/27/2018 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202611s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202611Orig1s011ltr.pdf
08/01/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/16/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202611s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202611Orig1s007ltr.pdf
08/10/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s006ltr.pdf
11/02/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s005ltr.pdf
02/09/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/19/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/04/2013 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
04/27/2018 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202611s011lbl.pdf
07/28/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202611s012lbl.pdf
08/16/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202611s007lbl.pdf
11/02/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s005lbl.pdf
08/10/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s006lbl.pdf
06/28/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202611s000lbl.pdf

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