Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219708
Company: QILU PHARMACEUTICAL CO., LTD.

Products on ANDA 219708

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.