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Setid 2150f73a 179b 4afc B8ce 67c85cc72f04 Applno 22334 Form Tablet Oral Dosage 7 5mg - Drug Product Composition: Everolimus

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$ API Ref.Price (USD/KG) : 272,439Xls

USFDA APPLICATION NUMBER - 22334 / DOSAGE - TABLET;ORAL - 7.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS(UNII: 9HW64Q8G6G)
(EVEROLIMUS - UNII:9HW64Q8G6G)
EVEROLIMUS7.5mg | 2mg | 3mg | 10mg | 2.5mg | 5mg | 5mg

Inactive Ingredients

Ingredient Name
Biocon Pharma Inc.
Novartis Pharmaceuticals Corporation
Par Pharmaceutical, Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
CROSPOVIDONE(2S7830E561) 
CROSPOVIDONE(68401960MK)  
HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU)  
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)  
HYPROMELLOSES(3NXW29V3WO)  
LACTOSE MONOHYDRATE(EWQ57Q8I5X) 
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)  
SILICON DIOXIDE(ETJ7Z6XBU4)