Details for New Drug Application (NDA): 219111
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NDA 219111 describes MIGLUSTAT, which is a drug marketed by Ani Pharms, Chartwell Rx, and Navinta Llc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the MIGLUSTAT profile page.
The generic ingredient in MIGLUSTAT 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 MIGLUSTAT 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 219111
| Tradename: | MIGLUSTAT |
| Applicant: | Navinta Llc |
| Ingredient: | miglustat |
| Patents: | 0 |
Pharmacology for NDA: 219111
| Mechanism of Action | Enzyme Stabilizers Glucosylceramide Synthase Inhibitors |
Suppliers and Packaging for NDA: 219111
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIGLUSTAT | miglustat | CAPSULE;ORAL | 219111 | ANDA | Navinta LLC | 68475-204 | 68475-204-02 | 6 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01) |
| MIGLUSTAT | miglustat | CAPSULE;ORAL | 219111 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-2039 | 70710-2039-8 | 6 BLISTER PACK in 1 CARTON (70710-2039-8) / 15 CAPSULE in 1 BLISTER PACK (70710-2039-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 14, 2025 | TE: | AB | RLD: | No | ||||
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