Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
COHANCE LIFESCIENCES LIMITED
Par Pharmaceutical, Inc.
677637710
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
49884-239Application Number
ANDA205724Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 12, 2023ItraconazoleActive
Code: 304NUG5GF4Class: ACTIBQuantity: 100 mg in 1 1
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT