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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218172

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NDA 218172 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 218172

Tradename:	MIRABEGRON
Applicant:	Ascent Pharms Inc
Ingredient:	mirabegron
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Sep 24, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Sep 24, 2025	TE:	AB	RLD:	No

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