Pharmaceutical drugs supplied by: AMICUS THERAPEUTICS US, LLC
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AMICUS THERAPEUTICS US, LLC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623 | NDA | Amicus Therapeutics US, LLC | 71904-100-01 | 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK | 2018-08-10 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
