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Setid E26e13c4 7e45 4e66 8c0d 7fc68e24cdd5 Applno 18044 Form Capsule Oral Dosage 0 5mcg - Drug Product Composition: Calcitriol Cryopharma Brand

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$ API Ref.Price (USD/KG) : 2,351,755Xls

USFDA APPLICATION NUMBER - 18044 / DOSAGE - CAPSULE;ORAL - 0.5MCG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL(UNII: FXC9231JVH)
(CALCITRIOL - UNII:FXC9231JVH)
CALCITRIOL0.5ug | 0.25ug

Inactive Ingredients

Ingredient Name
Cardinal Health
Teva Pharmaceuticals USA Inc
American Health Packaging
Amneal Pharmaceuticals LLC
Avera McKennan Hospital
BIONPHARMA INC.
Bryant Ranch Prepack
Golden State Medical Supply, Inc.
Heritage Pharmaceuticals Inc
KAISER FOUNDATION HOSPITALS
NuCare Pharmaceuticals,Inc.
AMMONIA(5138Q19F1X)         
BUTYLATED HYDROXYANISOLE(REK4960K2U)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
COCONUT OIL(Q9L0O73W7L)          
FD&C RED NO. 3(PN2ZH5LOQY)        
FD&C RED NO. 40(WZB9127XOA)     
FD&C YELLOW NO. 6(H77VEI93A8)   
FERRIC OXIDE RED(1K09F3G675)        
FERRIC OXIDE YELLOW(EX438O2MRT)        
FERROSOFERRIC OXIDE(XM0M87F357)      
GELATIN(2G86QN327L)  
GLYCERIN(PDC6A3C0OX)
ISOPROPYL ALCOHOL(ND2M416302)         
MANNITOL(3OWL53L36A)   
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
METHYLPARABEN SODIUM(CR6K9C2NHK)          
METHYLPARABEN(A2I8C7HI9T)          
PROPYLENE GLYCOL(6DC9Q167V3)        
PROPYLPARABEN SODIUM(625NNB0G9N)          
PROPYLPARABEN(Z8IX2SC1OH)          
SHELLAC(46N107B71O)         
SORBITAN(6O92ICV9RU)     
SORBITOL(506T60A25R) 
STARCH, CORN(O8232NY3SJ)          
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)