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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090199


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NDA 090199 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Generics, Granules, Hetero Labs Ltd Iii, 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-two NDAs. It is available from forty-six 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. Forty-eight suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 090199
Pharmacology for NDA: 090199
Suppliers and Packaging for NDA: 090199
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090199 ANDA Teva Pharmaceuticals USA, Inc. 0093-7701 0093-7701-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090199 ANDA PD-Rx Pharmaceuticals, Inc. 43063-479 43063-479-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 22, 2011TE:ABRLD:No

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