Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218662
Company: ZYDUS PHARMACEUTICALS (USA) INC.

Products on ANDA 218662

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UBROGEPANT	UBROGEPANT	50MG	TABLET	None (Tentative Approval)	None	No	No
UBROGEPANT	UBROGEPANT	100MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218662

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.