Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209821
Company: EDENBRIDGE PHARMS

Products on ANDA 209821

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209821

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2021	SUPPL-1	Labeling-Proprietary Name Change		Label is not available on this site.

Therapeutic Equivalents for ANDA 209821

YARGESA

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