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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219941
Company: DEVA HOLDING AS

Products on ANDA 219941

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219941

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219941

MIRABEGRON

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	219941	DEVA HOLDING AS
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209485	LUPIN
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	218543	MSN
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217989	QILU
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	219941	DEVA HOLDING AS
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209485	LUPIN
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	218543	MSN
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217989	QILU
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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