Last Updated: June 17, 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, 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 are nineteen drug master file entries for this compound. Nine 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

Pharmacology for NDA: 219323

Mechanism of Action	Adrenergic beta3-Agonists Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 219323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIRABEGRON	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	219323	ANDA	Ascend Laboratories, LLC	67877-890	67877-890-88	1 POUCH in 1 CARTON (67877-890-88) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE

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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