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Setid 3c4ab8b6 E8c6 415e 842b 57fb134fbab9 Applno 17812 Form Capsule Oral Dosage 600mg - Drug Product Composition: Lithium Carbonate

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$ API Ref.Price (USD/KG) : 77Xls

USFDA APPLICATION NUMBER - 17812 / DOSAGE - CAPSULE;ORAL - 600MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LITHIUM CARBONATE(UNII: 2BMD2GNA4V)
(LITHIUM CATION - UNII:8H8Z5UER66)
LITHIUM CARBONATE300mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
NuCare Pharmaceuticals, Inc.
REMEDYREPACK INC.
REMEDYREPACK INC.
Alembic Pharmaceuticals Inc.
American Health Packaging
Bryant Ranch Prepack
Glenmark Pharmaceuticals Inc., USA
NCS HealthCare of KY, LLC dba Vangard Labs
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc.
West-ward Pharmaceuticals Corp
NCS HealthCare of KY, Inc dba Vangard Labs
ALCOHOL(3K9958V90M)          
AMMONIA(5138Q19F1X)          
BUTYL ALCOHOL(8PJ61P6TS3)          
D&C YELLOW NO. 10(35SW5USQ3G)    
FD&C BLUE NO. 1(H3R47K3TBD)     
FD&C BLUE NO. 2(L06K8R7DQK)            
FD&C GREEN NO. 3(3P3ONR6O1S)            
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 6(H77VEI93A8)           
FERROSOFERRIC OXIDE(XM0M87F357) 
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)(0K9R94573C)            
GELATIN(2G86QN327L)         
GELATIN, UNSPECIFIED(2G86QN327L)    
ISOPROPYL ALCOHOL(ND2M416302)          
POTASSIUM HYDROXIDE(WZH3C48M4T)     
POVIDONE K30(U725QWY32X)          
PROPYLENE GLYCOL 1,2-DISTEARATE(T65PN3O37H)            
PROPYLENE GLYCOL(6DC9Q167V3)   
SHELLAC(46N107B71O)  
SILICON DIOXIDE(ETJ7Z6XBU4)     
SODIUM LAURYL SULFATE(368GB5141J)   
STEARIC ACID(4ELV7Z65AP)            
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)