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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209434

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NDA 209434 describes MIRABEGRON, which is a drug marketed by Alkem Labs Ltd, Apotex, Ascent Pharms Inc, Lupin Ltd, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the MIRABEGRON profile page.

The generic ingredient in MIRABEGRON is mirabegron. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mirabegron profile page.

Summary for 209434

Tradename:	MIRABEGRON
Applicant:	Apotex
Ingredient:	mirabegron
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Jan 2, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Jan 2, 2025	TE:		RLD:	No

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