Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219323

✉ Email this page to a colleague

« Back to Dashboard

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 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.