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
0093-7769Application Number
ANDA210050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 23, 2023BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 10 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Everolimus
Product Details
NDC Product Code
0093-7768Application Number
ANDA210050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 23, 2023BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 7.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Everolimus
Product Details
NDC Product Code
0093-7766Application Number
ANDA210050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 23, 2023CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 2.5 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Everolimus
Product Details
NDC Product Code
0093-7767Application Number
ANDA210050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 23, 2023EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 5 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT