Details for New Drug Application (NDA): 209821
✉ Email this page to a colleague
The generic ingredient in YARGESA 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 209821
Tradename: | YARGESA |
Applicant: | Edenbridge Pharms |
Ingredient: | miglustat |
Patents: | 0 |
Pharmacology for NDA: 209821
Mechanism of Action | Glucosylceramide Synthase Inhibitors |
Suppliers and Packaging for NDA: 209821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
YARGESA | miglustat | CAPSULE;ORAL | 209821 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-709 | 42799-709-15 | 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 6, 2020 | TE: | AB | RLD: | No |
Complete Access Available with Subscription