Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209543
Company: ALEMBIC

Products on ANDA 209543

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No
BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 500MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209543

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/09/2026	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209543

BOSUTINIB MONOHYDRATE

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSULIF	BOSUTINIB MONOHYDRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	203341	PF PRISM CV
BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	209543	ALEMBIC

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSULIF	BOSUTINIB MONOHYDRATE	EQ 500MG BASE	TABLET;ORAL	Prescription	Yes	AB	203341	PF PRISM CV
BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	209543	ALEMBIC