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FDA Approval

ZOLINZA

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 21, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vorinostat(100 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ZOLINZA

Product Details

NDC Product Code
0006-0568
Application Number
NDA021991
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
July 13, 2022
Code: 58IFB293JIClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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