Suppliers and packages for generic ingredient: MIGLUSTAT
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MIGLUSTAT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | MIGLUSTAT | miglustat | CAPSULE;ORAL | 208342 | ANDA | ANI Pharmaceuticals, Inc. | 43975-310-83 | 6 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08) | 2018-04-17 |
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211 | NDA | AMICUS THERAPEUTICS US, LLC | 71904-300-01 | 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC | 2023-10-11 |
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211 | NDA | AMICUS THERAPEUTICS US, LLC | 71904-300-02 | 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC | 2023-10-11 |
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211 | NDA | AMICUS THERAPEUTICS US, LLC | 71904-300-03 | 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC | 2023-10-11 |
| Edenbridge Pharms | YARGESA | miglustat | CAPSULE;ORAL | 209821 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-709-15 | 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK | 2020-08-06 |
| Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348 | NDA AUTHORIZED GENERIC | CoTherix, Inc. | 10148-201-90 | 6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15) | 2018-04-25 |
| Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-201-90 | 6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15) | 2003-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
