Iclusig

Product NDC
63020-534
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ponatinib hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA203469
Marketing category
NDA
Substance
PONATINIB HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
63020-534-3030 TABLET, FILM COATED in 1 BOTTLE (63020-534-30) 2012-12-14NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IclusigTakeda Pharmaceuticals America, Inc. | Catalent Greenville, Inc. | Patheon Inc. | Takeda Ireland Limited | Almac Sciences (Ireland) Limited2026-04-29HUMAN PRESCRIPTION DRUG LABEL19
IclusigTakeda Pharmaceuticals America, Inc. | Ash Stevens LLC | Catalent Micron Technologies, Inc. | Catalent Pharma Solutions, LLC | Sharp Packaging Services, LLC | Patheon Inc. | Takeda Ireland Limited | Almac Sciences (Ireland) Limited2024-12-19HUMAN PRESCRIPTION DRUG LABEL17