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Details for New Drug Application (NDA): 202673

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NDA 202673 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, Synthon Pharms, Micro Labs Ltd India, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, L Perrigo Co, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro Pharm Inds, Glenmark Generics, Sandoz, Dr Reddys Labs Ltd, and Teva Pharms, and is included in fifteen NDAs. It is available from twenty-five 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for NDA: 202673

Pharmacology for NDA: 202673

Suppliers and Packaging for NDA: 202673

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
SOLUTION;ORAL 202673 ANDA Taro Pharmaceuticals U.S.A., inc. 51672-4161 51672-4161-1 1 BOTTLE in 1 CARTON (51672-4161-1) > 237 mL in 1 BOTTLE
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
SOLUTION;ORAL 202673 ANDA Taro Pharmaceuticals U.S.A., inc. 51672-4161 51672-4161-4 1 BOTTLE in 1 CARTON (51672-4161-4) > 59 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2.5MG/5ML
Approval Date:Jul 26, 2013TE:AARLD:No


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