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.
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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215211
| Mechanism of Action | 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: | ⤷ Try a Trial | Patent Expiration: | Sep 30, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | THE TREATMENT OF POMPE PATIENTS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | THE TREATMENT OF POMPE PATIENTS | ||||||||
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