Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
West-Ward Columbus Inc.
Hikma Pharmaceuticals USA Inc.
058839929
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Everolimus
Product Details
NDC Product Code
0054-0472Application Number
ANDA206133Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 18, 2023BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 0.75 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Everolimus
Product Details
NDC Product Code
0054-0604Application Number
ANDA206133Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 18, 2023EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 1 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Everolimus
Product Details
NDC Product Code
0054-0470Application Number
ANDA206133Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 18, 2023EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 0.25 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
Everolimus
Product Details
NDC Product Code
0054-0471Application Number
ANDA206133Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 18, 2023EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 0.5 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT