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Drug Product Composition: Tetrahydrocannabinol

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USFDA APPLICATION NUMBER - 18651 / DOSAGE - CAPSULE;ORAL - 5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dronabinol(UNII: 7J8897W37S)
(dronabinol - UNII:7J8897W37S)
dronabinol10mg | 5mg | 2.5mg

Inactive Ingredients

Ingredient Name
American Health Packaging
Major Pharmaceuticals
Mylan Pharmaceuticals Inc.
Par Pharmaceutical, Inc.
AvKARE
Camber Pharmaceuticals Inc
Lannett Company, Inc.
AbbVie Inc.
Actavis Pharma, Inc.
Ascend Laboratories, LLC
Bryant Ranch Prepack
ammonia(5138Q19F1X)       
BUTYL ALCOHOL(8PJ61P6TS3)        
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)        
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)
HYPROMELLOSES(3NXW29V3WO)        
isopropyl alcohol(ND2M416302)    
LECITHIN, SOYBEAN(1DI56QDM62)        
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)          
polyvinyl acetate phthalate(58QVG85GW3)          
Propylene glycol(6DC9Q167V3)    
SESAME OIL(QX10HYY4QV)
SHELLAC(46N107B71O)        
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)