Last Updated: September 28, 2026

Details for New Drug Application (NDA): 209446

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NDA 209446 describes MIRABEGRON, which is a drug marketed by Alkem Labs Ltd, Apotex, Deva Holding As, Lupin, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the MIRABEGRON profile page.

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

Summary for 209446

Tradename:	MIRABEGRON
Applicant:	Sawai Usa
Ingredient:	mirabegron
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Dec 27, 2019	TE:		RLD:	No

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