Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Accord Healthcare Inc.
604222237
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Intas Pharmaceuticals Ltd
Accord Healthcare Inc.
Accord Healthcare Inc.
725927649
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
16729-271Application Number
ANDA205991Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 2, 2023GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ItraconazoleActive
Code: 304NUG5GF4Class: ACTIBQuantity: 100 mg in 1 1
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT