Details for New Drug Application (NDA): 208342
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NDA 208342 describes MIGLUSTAT, which is a drug marketed by Ani Pharms and Breckenridge and is included in two NDAs. It is available from one supplier. 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the miglustat profile page.
Summary for 208342
| Tradename: | MIGLUSTAT |
| Applicant: | Ani Pharms |
| Ingredient: | miglustat |
| Patents: | 0 |
Pharmacology for NDA: 208342
| Mechanism of Action | Enzyme Stabilizers Glucosylceramide Synthase Inhibitors |
Suppliers and Packaging for NDA: 208342
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIGLUSTAT | miglustat | CAPSULE;ORAL | 208342 | ANDA | ANI Pharmaceuticals, Inc. | 43975-310 | 43975-310-83 | 6 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 17, 2018 | TE: | AB | RLD: | No | ||||
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