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FDA Approval

Itraconazole

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

FDA Approval Summary

Company
AvPAK
DUNS: 832926666
Effective Date
January 9, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Itraconazole(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.

Itraconazole

Product Details

NDC Product Code
50268-450
Application Number
ANDA205080
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
Code: 304NUG5GF4Class: ACTIBQuantity: 100 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
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