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Drug Product Composition: Levocetirizine Dihydrochloride

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$ API Ref.Price (USD/KG) : 660Xls

USFDA APPLICATION NUMBER - 22064 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levocetirizine dihydrochloride(UNII: SOD6A38AGA)
(levocetirizine - UNII:6U5EA9RT2O)
levocetirizine dihydrochloride5mg

Inactive Ingredients

Ingredient Name
Sanofi-Aventis U.S. LLC
UCB, Inc.
Winthrop U.S.
Lake Erie Medical DBA Quality Care Products LLC
UCB Farchim S.A.
Valeant Pharmaceuticals International Inc.
.alpha.-tocopherol, dl-(7QWA1RIO01)   
acetic acid(Q40Q9N063P)   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
FD&C Red No. 40(WZB9127XOA)     
glycerin(PDC6A3C0OX)   
hypromellose(3NXW29V3WO)     
hypromellose, unspecified(3NXW29V3WO)   
hypromelloses(3NXW29V3WO)    
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
maltitol(D65DG142WK)   
methylparaben(A2I8C7HI9T)   
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
polyethylene glycol 400(B697894SGQ)  
propylparaben(Z8IX2SC1OH)   
saccharin(FST467XS7D)   
shellac(46N107B71O)     
silicon dioxide(ETJ7Z6XBU4)  
sodium acetate(4550K0SC9B)   
titanium dioxide(15FIX9V2JP) 
triacetin(XHX3C3X673)   
water(059QF0KO0R)