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Drug Product Composition: Atorvastatin

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$ API Ref.Price (USD/KG) : 219Xls

USFDA APPLICATION NUMBER - 21540 / DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288)
AMLODIPINE10mg | 10mg | 10mg | 10mg | 5mg | 5mg | 5mg | 5mg | 2.5mg | 2.5mg | 2.5mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F)
ATORVASTATIN80mg | 40mg | 20mg | 10mg | 80mg | 40mg | 20mg | 10mg | 40mg | 20mg | 10mg

Inactive Ingredients

Ingredient Name
Mylan Pharmaceuticals Inc.
Pfizer Laboratories Div Pfizer Inc
Ranbaxy Pharmaceuticals Inc
Zydus Pharmaceuticals (USA) Inc.
Dr. Reddy's Laboratories Inc
ARGININE(94ZLA3W45F)    
CALCIUM CARBONATE(H0G9379FGK) 
cellulose, microcrystalline(OP1R32D61U) 
CROSCARMELLOSE SODIUM(M28OL1HH48) 
Crospovidone(2S7830E561)    
FD&C BLUE NO. 2(L06K8R7DQK)
Hydrogenated Soybean Lecithin(H1109Z9J4N)    
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)    
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)   
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)  
HYPROMELLOSES(3NXW29V3WO)    
LECITHIN, SOYBEAN(1DI56QDM62)    
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
POLYETHYLENE GLYCOL 3000(SA1B764746)  
polyethylene glycol 3350(G2M7P15E5P)    
POLYSORBATE 80(6OZP39ZG8H) 
POLYVINYL ALCOHOL(532B59J990)   
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)  
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium bicarbonate(8MDF5V39QO)    
SODIUM CARBONATE(45P3261C7T)    
sodium lauryl sulfate(368GB5141J)    
STARCH, CORN(O8232NY3SJ)  
TALC(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
WATER(059QF0KO0R)  
XANTHAN GUM(TTV12P4NEE)