Details for New Drug Application (NDA): 021348
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The generic ingredient in ZAVESCA 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.
Pharmacology for NDA: 021348
Mechanism of Action | Glucosylceramide Synthase Inhibitors |
Suppliers and Packaging for NDA: 021348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZAVESCA | miglustat | CAPSULE;ORAL | 021348 | NDA AUTHORIZED GENERIC | CoTherix, Inc. | 10148-201 | 10148-201-90 | 6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15) |
ZAVESCA | miglustat | CAPSULE;ORAL | 021348 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-201 | 66215-201-90 | 6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 31, 2003 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021348
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | 5,472,969 | ⤷ Subscribe |
Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | 5,525,616 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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