Details for New Drug Application (NDA): 209821
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NDA 209821 describes YARGESA, which is a drug marketed by Edenbridge Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the YARGESA profile page.
The generic ingredient in YARGESA is miglustat. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the miglustat profile page.
The generic ingredient in YARGESA is miglustat. There are two drug master file entries for this compound. Seven 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 | Enzyme Stabilizers 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 | ||||
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