Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209624
Company: MSN

Products on ANDA 209624

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BOSUTINIB	BOSUTINIB MONOHYDRATE	EQ 100MG BASE	TABLET;FILM COATED	None (Tentative Approval)	None	No	No
BOSUTINIB	BOSUTINIB MONOHYDRATE	EQ 500MG BASE	TABLET;FILM COATED	None (Tentative Approval)	None	No	No
BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209624

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2026	ORIG-2	Tentative Approval		STANDARD		Label is not available on this site.
05/28/2025	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209624Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 209624

BOSUTINIB

There are no Therapeutic Equivalents.

BOSUTINIB MONOHYDRATE

TABLET;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSULIF	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET;ORAL	Prescription	Yes	AB	203341	PF PRISM CV
BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	209624	MSN