Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213801
Company: APGDI

Products on NDA 213801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYRBETRIQ GRANULES	MIRABEGRON	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202611s017,213801s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213801Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213801Orig1s000TOC.html

Labels for NDA 213801

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202611s017,213801s000lbl.pdf

Therapeutic Equivalents for NDA 213801

MYRBETRIQ GRANULES

FOR SUSPENSION, EXTENDED RELEASE;ORAL; 8MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRABEGRON	MIRABEGRON	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	No	AB	219323	ALKEM LABS LTD
MYRBETRIQ GRANULES	MIRABEGRON	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	213801	APGDI