MedPath
FDA Product

Zydelig

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Zydelig

61958-1701

Regulatory Information

61958-1701

NDA205858

C73594

February 28, 2022

USA

These highlights do not include all the information needed to use ZYDELIG safely and effectively. See full prescribing information for ZYDELIG. ZYDELIG® (idelalisib) tablets, for oral use Initial U.S. Approval: 2014

HUMAN PRESCRIPTION DRUG LABEL

11

Company Information

185049848

Active Ingredients

IDELALISIB

Quantity: 100 mg in 1 1

Code: YG57I8T5M0

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

Active Moieties

IDELALISIB

Code: YG57I8T5M0

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