Details for New Drug Application (NDA): 215211
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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
Mechanism of Action | Enzyme Stabilizers Glucosylceramide Synthase Inhibitors |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 65MG | ||||
Approval Date: | Sep 28, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Sep 28, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 30, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | THE TREATMENT OF POMPE PATIENTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 7, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | THE TREATMENT OF POMPE PATIENTS |
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