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FDA Approval

Everolimus

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 30, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Everolimus(0.25 mg in 1 1)

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
49884-158
Application Number
ANDA205775
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 21, 2022
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
Code: 9HW64Q8G6GClass: ACTIBQuantity: 0.25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Everolimus

Product Details

NDC Product Code
49884-159
Application Number
ANDA205775
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 21, 2022
Code: 9HW64Q8G6GClass: ACTIBQuantity: 0.5 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT

Everolimus

Product Details

NDC Product Code
49884-160
Application Number
ANDA205775
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 21, 2022
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
Code: 9HW64Q8G6GClass: ACTIBQuantity: 0.75 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Everolimus

Product Details

NDC Product Code
49884-283
Application Number
ANDA205775
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 21, 2022
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
Code: 9HW64Q8G6GClass: ACTIBQuantity: 1 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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