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Setid 7dec6ce7 Cd5f 43be B050 B8103d35f0bc Applno 18482 Form Capsule Oral Dosage 10mg - Drug Product Composition: NCGC00024983-01

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$ API Ref.Price (USD/KG) : 76Xls

USFDA APPLICATION NUMBER - 18482 / DOSAGE - CAPSULE;ORAL - 10MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE(UNII: I9ZF7L6G2L)
(NIFEDIPINE - UNII:I9ZF7L6G2L)
NIFEDIPINE10mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
American Health Packaging
AvPAK
Cardinal Health
Acella Pharmaceuticals, LLC
Bryant Ranch Prepack
Golden State Medical Supply, Inc.
PD-Rx Pharmaceuticals, Inc.
Pfizer Laboratories Div Pfizer Inc
REMEDYREPACK INC.
A-S Medication Solutions LLC
AMMONIA(5138Q19F1X)        
BROWN IRON OXIDE(1N032N7MFO)        
FD&C BLUE NO. 1(H3R47K3TBD)      
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)   
GELATIN, UNSPECIFIED(2G86QN327L)         
GLYCERIN(PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
HYPROMELLOSES(3NXW29V3WO)         
ISOBUTYL ALCOHOL(56F9Z98TEM)         
MENTHOL(L7T10EIP3A)       
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)          
PEPPERMINT OIL(AV092KU4JH)    
POLYETHYLENE GLYCOL(3WJQ0SDW1A)        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)       
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)      
Polyvinyl Acetate Phthalate(58QVG85GW3)        
POVIDONE K30(U725QWY32X)       
PROPYLENE GLYCOL(6DC9Q167V3)      
SACCHARIN SODIUM ANHYDROUS(I4807BK602)          
SACCHARIN SODIUM(SB8ZUX40TY)          
SHELLAC(46N107B71O)      
SORBITAN(6O92ICV9RU)      
SORBITOL(506T60A25R)      
TITANIUM DIOXIDE(15FIX9V2JP)  
WATER BUFFALO, COOKED(RM3G76I0A1)          
WATER(059QF0KO0R)