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Drug Product Composition: Clavulanic Acid

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$ API Ref.Price (USD/KG) : 79Xls

USFDA APPLICATION NUMBER - 50725 / DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
AMOXICILLIN ANHYDROUS400mg in 5
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24)
CLAVULANIC ACID57mg in 5

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Mylan Pharmaceuticals Inc.
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
A-S Medication Solutions LLC
Aurobindo Pharma Limited
Hikma Pharmaceutical
Hikma Pharmaceuticals USA Inc.
NorthStar Rx LLC
REMEDYREPACK INC.
Sandoz GmbH
Sandoz Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)        
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)          
ASPARTAME(Z0H242BBR1)
BANANA(4AJZ4765R9)            
CARAMEL(T9D99G2B1R)          
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)             
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)            
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)             
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)             
CETYL ALCOHOL(936JST6JCN)            
CHERRY(BUC5I9595W)            
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)             
CROSCARMELLOSE SODIUM(M28OL1HH48)             
CROSPOVIDONE (120 .MU.M)(68401960MK)            
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)             
DEXTROSE(IY9XDZ35W2)             
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)           
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)           
FD&C RED NO. 40(WZB9127XOA)            
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)             
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)       
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)         
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
HYPROMELLOSES(3NXW29V3WO)            
MAGNESIUM STEARATE(70097M6I30)           
MANNITOL(3OWL53L36A)     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)         
ORANGE(5EVU04N5QU)    
POLYSORBATE 80(6OZP39ZG8H)             
RASPBERRY(4N14V5R27W)          
SACCHARIN SODIUM(SB8ZUX40TY)       
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM CITRATE(1Q73Q2JULR)             
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)           
SODIUM LAURYL SULFATE(368GB5141J)            
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)            
SUCCINIC ACID(AB6MNQ6J6L)  
TALC(7SEV7J4R1U)           
TITANIUM DIOXIDE(15FIX9V2JP)           
TRIETHYL CITRATE(8Z96QXD6UM)           
XANTHAN GUM(TTV12P4NEE)