Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Biocon Pharma Limited
871412155
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Biocon Limited
Biocon Pharma Inc.
Biocon Pharma Limited
915076162
Biocon Pharma Limited
Biocon Pharma Inc.
Biocon Pharma Limited
871412155
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
70377-012Application Number
ANDA214182Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 2, 2023EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 7.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBUClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
EVEROLIMUS
Product Details
NDC Product Code
70377-010Application Number
ANDA214182Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 2, 2023CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBUClass: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 2.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
EVEROLIMUS
Product Details
NDC Product Code
70377-013Application Number
ANDA214182Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 2, 2023CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBUClass: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
EVEROLIMUS
Product Details
NDC Product Code
70377-011Application Number
ANDA214182Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 2, 2023EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 5 mg in 1 1
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT