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Setid 5ce71761 Aebc 481b B31b 05201c8a9d23 Applno 3444 Form Capsule Oral Dosage 50 000 Iu - Drug Product Composition: Vitamin D2

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$ API Ref.Price (USD/KG) : 793Xls

USFDA APPLICATION NUMBER - 3444 / DOSAGE - CAPSULE;ORAL - 50,000 IU

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ergocalciferol(UNII: VS041H42XC)
(ergocalciferol - UNII:VS041H42XC)
ergocalciferol1.25mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
A-S Medication Solutions LLC
Bryant Ranch Prepack
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Sun Pharmaceutical Industries, Inc.
Clinical Solutions Wholesale
Unit Dose Services
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
American Health Packaging
Breckenridge Pharmaceutical, Inc.
Golden State Medical Supply, Inc.
KAISER FOUNDATION HOSPITALS
Lake Erie Medical DBA Quality Care Products LLC
Pliva Inc.
St Marys Medical Park Pharmacy
Avera McKennan Hospital
REMEDYREPACK INC.
sanofi-aventis U.S. LLC
Validus Pharmaceuticals LLC
Winthrop U.S.
AMMONIA(5138Q19F1X)               
BENZYL ALCOHOL(LKG8494WBH)                    
BUTYL ALCOHOL(8PJ61P6TS3)               
BUTYLATED HYDROXYANISOLE(REK4960K2U)                     
BUTYLPARABEN(3QPI1U3FV8)                    
D&C YELLOW NO. 10(35SW5USQ3G)     
DIMETHICONE(92RU3N3Y1O)              
ETHYLENE GLYCOL MONOETHYL ETHER(IDK7C2HS09)                    
FD&C Blue No. 1(H3R47K3TBD) 
FD&C YELLOW NO. 5(I753WB2F1M)                 
Gelatin(2G86QN327L)        
GELATIN, UNSPECIFIED(2G86QN327L)           
GLYCERIN(PDC6A3C0OX)  
ISOPROPYL ALCOHOL(ND2M416302)               
LECITHIN, SOYBEAN(1DI56QDM62)                    
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)                    
METHYLPARABEN(A2I8C7HI9T)                    
POLYSORBATE 80(6OZP39ZG8H)                    
PROPYLENE GLYCOL(6DC9Q167V3)              
PROPYLPARABEN(Z8IX2SC1OH)                    
SHELLAC(46N107B71O)            
SODIUM LAURYL SULFATE(368GB5141J)                    
SOYBEAN OIL(241ATL177A)
TITANIUM DIOXIDE(15FIX9V2JP)            
Water(059QF0KO0R)