Drug Safety Labeling Changes (SLC)
IMBRUVICA (NDA-205552)
(IBRUTINIB)
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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 |
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