Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219323
Company: ALKEM LABS LTD

Products on ANDA 219323

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRABEGRON	MIRABEGRON	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219323Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 219323

MIRABEGRON

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