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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 219323

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NDA 219323 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 ten 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 219323

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;ORAL			Strength	8MG/ML
Approval Date:	Jan 20, 2026	TE:	AB	RLD:	No

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