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Setid Bf602097 9017 4bdf 9232 454829001121 Applno 84768 Form Capsule Oral Dosage 5mg - Drug Product Composition: Librium

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USFDA APPLICATION NUMBER - 84768 / DOSAGE - CAPSULE;ORAL - 5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE(UNII: MFM6K1XWDK)
(CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)
CHLORDIAZEPOXIDE HYDROCHLORIDE25mg | 10mg | 5mg

Inactive Ingredients

Ingredient Name
Cardinal Health
Mylan Institutional Inc.
REMEDYREPACK INC.
AvKARE, Inc.
Solco Healthcare US LLC
ALUMINUM OXIDE(LMI26O6933)    
ANHYDROUS LACTOSE(3SY5LH9PMK)  
BUTYLPARABEN(3QPI1U3FV8)   
D&C RED NO. 33(9DBA0SBB0L)  
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)   
D&C YELLOW NO. 10(35SW5USQ3G)
DIMETHICONE(92RU3N3Y1O)   
EDETATE CALCIUM DISODIUM(25IH6R4SGF)    
ETHYLENE GLYCOL MONOETHYL ETHER(IDK7C2HS09)   
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)   
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)   
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)   
FD&C GREEN NO. 3(3P3ONR6O1S)   
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)   
FERROSOFERRIC OXIDE(XM0M87F357)  
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)   
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)   
LECITHIN, SOYBEAN(1DI56QDM62)   
METHYLPARABEN(A2I8C7HI9T) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)  
POTASSIUM SORBATE(1VPU26JZZ4)   
PROPYLENE GLYCOL(6DC9Q167V3)  
PROPYLPARABEN(Z8IX2SC1OH) 
SHELLAC(46N107B71O)  
SODIUM LAURYL SULFATE(368GB5141J)   
SODIUM PROPIONATE(DK6Y9P42IN)   
SODIUM(9NEZ333N27)    
STARCH, CORN(O8232NY3SJ)   
TALC(7SEV7J4R1U)   
TITANIUM DIOXIDE(15FIX9V2JP)