Details for New Drug Application (NDA): 209325

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NDA 209325 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.

Summary for 209325

Tradename:	MIGLUSTAT
Applicant:	Breckenridge
Ingredient:	miglustat
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Feb 3, 2022	TE:	AB	RLD:	No

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