Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217786
Company: AUROBINDO PHARMA LIMITED

Products on ANDA 217786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIGALASTAT	MIGALASTAT HYDROCHLORIDE	123MG	CAPSULE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217786

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.