Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
918596198
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
68382-697Application Number
ANDA204672Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2022AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ItraconazoleActive
Code: 304NUG5GF4Class: ACTIBQuantity: 100 mg in 1 1
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8Class: IACT