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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204599


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NDA 204599 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Us Antibiotics, and is included in twenty-three NDAs. It is available from forty-nine suppliers. Additional details are available on the LEVOCETIRIZINE DIHYDROCHLORIDE profile page.

The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 204599
Pharmacology for NDA: 204599
Suppliers and Packaging for NDA: 204599
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 204599 ANDA Chartwell RX, LLC 62135-917 62135-917-38 148 mL in 1 BOTTLE (62135-917-38)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2.5MG/5ML
Approval Date:May 15, 2017TE:AARLD:No

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