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Drug Product Composition: Desloratadine

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$ API Ref.Price (USD/KG) : 911Xls

USFDA APPLICATION NUMBER - 21300 / DOSAGE - SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Desloratadine(UNII: FVF865388R)
(Desloratadine - UNII:FVF865388R)
Desloratadine0.5mg in 1 | 5mg

Inactive Ingredients

Ingredient Name
Merck Sharp & Dohme Corp.
Aluminum Oxide(LMI26O6933)
anhydrous citric acid(XF417D3PSL)
carnauba wax(R12CBM0EIZ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
edetate disodium(7FLD91C86K)
FD&C Blue No. 2(L06K8R7DQK)
FD&C Yellow No. 6(H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
propylene glycol(6DC9Q167V3)
sodium benzoate(OJ245FE5EU)
sorbitol(506T60A25R)
starch, corn(O8232NY3SJ)
sucrose(C151H8M554)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
trisodium citrate dihydrate(B22547B95K)
water(059QF0KO0R)
white wax(7G1J5DA97F)