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Drug Product Composition: Restasis

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$ API Ref.Price (USD/KG) : 1,308Xls

USFDA APPLICATION NUMBER - 50715 / DOSAGE - CAPSULE;ORAL - 100MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE(UNII: 83HN0GTJ6D)
(CYCLOSPORINE - UNII:83HN0GTJ6D)
CYCLOSPORINE25mg

Inactive Ingredients

Ingredient Name
Cardinal Health
IVAX Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Eon Labs, Inc.
Actavis Pharma, Inc.
.ALPHA.-TOCOPHEROL, DL-(7QWA1RIO01)  
ALCOHOL(3K9958V90M) 
ALPHA-TOCOPHEROL(H4N855PNZ1)    
ALUMINUM OXIDE(LMI26O6933)   
BROWN IRON OXIDE(1N032N7MFO)   
COCHINEAL(TZ8Z31B35M)    
CORN OIL(8470G57WFM)    
FD&C BLUE NO. 2(L06K8R7DQK)   
FERRIC OXIDE RED(1K09F3G675)    
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERROSOFERRIC OXIDE(XM0M87F357)    
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L)   
GLYCERIN(PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE(TM2TZD4G4A)    
GLYCERYL MONOLINOLEATE(4763AXI84L)    
GLYCINE(TE7660XO1C)  
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)    
NONCRYSTALLIZING SORBITOL SOLUTION(9E0S3UM200)    
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES(00BT03FSO2)    
POLYETHYLENE GLYCOL 400(B697894SGQ)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
POLYGLYCERYL-10 OLEATE(55C81W76DH)    
POLYGLYCERYL-3 OLEATE(XRQ165498B)    
POLYOXYL 35 CASTOR OIL(6D4M1DAL6O)   
POLYOXYL 40 HYDROGENATED CASTOR OIL(7YC686GQ8F) 
POLYSORBATE 80(6OZP39ZG8H)    
PROPYLENE GLYCOL(6DC9Q167V3)  
SHELLAC(46N107B71O)   
SORBITAN MONOOLEATE(06XEA2VD56)    
SORBITOL(506T60A25R) 
TITANIUM DIOXIDE(15FIX9V2JP) 
TOCOPHEROL(R0ZB2556P8)    
TOCOPHERSOLAN(O03S90U1F2)