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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202611
Company: APGDI

Products on NDA 202611

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYRBETRIQ	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes
MYRBETRIQ	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202611

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
03/25/2021	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202611s017,213801s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202611Orig1s017ltr.pdf
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.

Labels for NDA 202611

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2021	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202611s017,213801s000lbl.pdf
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

Therapeutic Equivalents for NDA 202611

MYRBETRIQ

TABLET, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215948	ALKEM LABS LTD
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209485	LUPIN LTD
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209488	ZYDUS PHARMS
MYRBETRIQ	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202611	APGDI

TABLET, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215948	ALKEM LABS LTD
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209485	LUPIN LTD
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209488	ZYDUS PHARMS
MYRBETRIQ	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202611	APGDI

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