Drug Safety Labeling Changes (SLC)

IMBRUVICA (NDA-205552)

(IBRUTINIB)

Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

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ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	021842	NDA	12/21/2017	12/26/2017
ACTOPLUS MET XR	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	022024	NDA	12/21/2017	12/26/2017
ACTOS	PIOGLITAZONE HYDROCHLORIDE	021073	NDA	12/21/2017	12/26/2017
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	021925	NDA	12/21/2017	12/26/2017
ICLUSIG	PONATINIB HYDROCHLORIDE	203469	NDA	12/20/2017	12/26/2017
IMBRUVICA	IBRUTINIB	205552	NDA	12/20/2017	12/26/2017
TASIGNA	NILOTINIB HYDROCHLORIDE MONOHYDRATE	022068	NDA