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Drug Product Composition: Hydrocortisone Probutate

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$ API Ref.Price (USD/KG) : 8,095Xls

USFDA APPLICATION NUMBER - 20453 / DOSAGE - CREAM;TOPICAL - 0.1%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE PROBUTATE(UNII: O6550D6K3A)
(HYDROCORTISONE - UNII:WI4X0X7BPJ)
HYDROCORTISONE PROBUTATE1mg in 1

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
Bausch Health US, LLC
Oceanside Pharmaceuticals
PharmaDerm a division of Fougera Pharmaceuticals Inc.
Metacon Labs
REMEDYREPACK INC.
Rouses Point Pharm
ANHYDROUS CITRIC ACID(XF417D3PSL)    
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)      
BUTYLPARABEN(3QPI1U3FV8)
CETETH-20(I835H2IHHX) 
CETOSTEARYL ALCOHOL(2DMT128M1S) 
CITRIC ACID MONOHYDRATE(2968PHW8QP)   
GLYCERYL MONOSTEARATE(230OU9XXE4)      
GLYCERYL STEARATE SE(FCZ5MH785I)      
LIGHT MINERAL OIL(N6K5787QVP)      
METHYLPARABEN(A2I8C7HI9T)      
MINERAL OIL(T5L8T28FGP) 
PEG-20 STEARATE(NBX892EA57)      
PETROLATUM(4T6H12BN9U)
POLYSORBATE 60(CAL22UVI4M)      
PROPYLENE GLYCOL(6DC9Q167V3)      
PROPYLPARABEN(Z8IX2SC1OH) 
SODIUM CITRATE(1Q73Q2JULR)   
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)     
SORBITAN MONOSTEARATE(NVZ4I0H58X)      
STEARYL ALCOHOL(2KR89I4H1Y)      
WATER(059QF0KO0R)