Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Annora Pharma Private Limited
Natco Pharma USA LLC
650980746
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Itraconazole Oral
Product Details
NDC Product Code
69339-159Application Number
ANDA212239Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 11, 2022ascorbic acidInactive
Code: PQ6CK8PD0RClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
ItraconazoleActive
Code: 304NUG5GF4Class: ACTIBQuantity: 10 mg in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
noncrystallizing sorbitol solutionInactive
Code: 9E0S3UM200Class: IACT
saccharin sodiumInactive
Code: SB8ZUX40TYClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT