Levocetirizine Dihydrochloride

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ACTIVE PHARMA INGREDIENTS

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1 Drugs in Development

INTERMEDIATES

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9 API Suppliers

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 29 FDA Orange Book, 60 Europe, 39 South Africa, 88 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 2.5MG/5ML, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 US Patents

REF. STANDARDS & IMPURITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 209090 / DOSAGE - SOLUTION;ORAL - 2.5MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOCETIRIZINE DIHYDROCHLORIDE(UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5mg in 5 \| 2.5mg in 5 \| 2.5mg in 5

Inactive Ingredients

Ingredient Name	Apotex Corp.	Chattem, Inc.	Lannett Company, Inc.
ACETIC ACID(Q40Q9N063P)
GLYCERIN(PDC6A3C0OX)
MALTITOL(D65DG142WK)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM ACETATE(4550K0SC9B)
SUCRALOSE(96K6UQ3ZD4)
WATER(059QF0KO0R)

Drug Product Composition: Levocetirizine Dihydrochloride