Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209488
Company: ZYDUS PHARMS

Products on ANDA 209488

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 209488

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209488Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 209488

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	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