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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 213801


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NDA 213801 describes MYRBETRIQ GRANULES, which is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MYRBETRIQ GRANULES profile page.

The generic ingredient in MYRBETRIQ GRANULES is mirabegron. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 213801
Tradename:MYRBETRIQ GRANULES
Applicant:Apgdi
Ingredient:mirabegron
Patents:3
Suppliers and Packaging for NDA: 213801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYRBETRIQ GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801 NDA Astellas Pharma US, Inc. 0469-5020 0469-5020-99 1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;ORALStrength8MG/ML
Approval Date:Mar 25, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 25, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Sep 25, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Try a TrialPatent Expiration:Oct 1, 2036Product Flag?Substance Flag?Delist Request?Y

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