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Approved Drug Products containing NCGC00024452-04 listed in the FDA Orange Book. Original Data : FDA Website

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01 1BRECKENRIDGE

02 1ACTELION

03 1AMICUS THERAP US

04 1ANI PHARMS

05 1EDENBRIDGE PHARMS

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PharmaCompass

01

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MIGLUSTAT

Brand Name : MIGLUSTAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2022-02-03

Application Number : 209325

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

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MIGLUSTAT

Brand Name : ZAVESCA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2003-07-31

Application Number : 21348

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

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MIGLUSTAT

Brand Name : OPFOLDA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 65MG

Approval Date : 2023-09-28

Application Number : 215211

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

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MIGLUSTAT

Brand Name : MIGLUSTAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2018-04-17

Application Number : 208342

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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MIGLUSTAT

Brand Name : YARGESA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2020-08-06

Application Number : 209821

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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