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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219552
Company: SANDOZ INC

Products on ANDA 219552

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMIGATINIB	PEMIGATINIB	13.5MG	TABLET	None (Tentative Approval)	None	No	No
PEMIGATINIB	PEMIGATINIB	4.5MG	TABLET	None (Tentative Approval)	None	No	No
PEMIGATINIB	PEMIGATINIB	9MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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