Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215948

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NDA 215948 describes MIRABEGRON, which is a drug marketed by Alkem Labs Ltd, Apotex, Creekwood Pharms, Deva Holding As, Lupin, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in eleven NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the mirabegron profile page.

Summary for 215948

Tradename:	MIRABEGRON
Applicant:	Alkem Labs Ltd
Ingredient:	mirabegron
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Feb 12, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Feb 12, 2024	TE:	AB	RLD:	No

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