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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 215211


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NDA 215211 describes OPFOLDA, which is a drug marketed by Amicus Therap Us and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the OPFOLDA profile page.

The generic ingredient in OPFOLDA is miglustat. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the miglustat profile page.
Summary for 215211
Tradename:OPFOLDA
Applicant:Amicus Therap Us
Ingredient:miglustat
Patents:7
Pharmacology for NDA: 215211
Suppliers and Packaging for NDA: 215211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPFOLDA miglustat CAPSULE;ORAL 215211 NDA AMICUS THERAPEUTICS US, LLC 71904-300 71904-300-01 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC
OPFOLDA miglustat CAPSULE;ORAL 215211 NDA AMICUS THERAPEUTICS US, LLC 71904-300 71904-300-02 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength65MG
Approval Date:Sep 28, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 28, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:10,208,299Patent Expiration:Sep 30, 2035Product Flag?YSubstance Flag?YDelist Request?
Patented Use:THE TREATMENT OF POMPE PATIENTS
Patent:10,512,677Patent Expiration:Mar 7, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF POMPE PATIENTS

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