Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219960
Company: XIROMED PHARMA ESPANA, S.L.

Products on ANDA 219960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULIPRISTAL ACETATE	ULIPRISTAL ACETATE	30MG, 30MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219960

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.