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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219205
Company: QILU PHARM HAINAN

Products on ANDA 219205

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLAPARIB	OLAPARIB	100MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
OLAPARIB	OLAPARIB	150MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219205

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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