Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208342
Company: ANI PHARMS

Products on ANDA 208342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIGLUSTAT	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208342Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2021	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208342

MIGLUSTAT

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIGLUSTAT	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	No	AB	208342	ANI PHARMS
MIGLUSTAT	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	No	AB	209325	BRECKENRIDGE
YARGESA	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	No	AB	209821	EDENBRIDGE PHARMS
ZAVESCA	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	Yes	AB	021348	ACTELION