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Levocetirizine dihydrochloride - Generic Drug Details

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Levocetirizine dihydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Synthon Pharms, Micro Labs Ltd India, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Ucb Inc, 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 seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for levocetirizine dihydrochloride. Twenty-seven suppliers are listed for this compound.

Summary for Generic Name: levocetirizine dihydrochloride

Tradenames:2
Patents:0
Applicants:15
NDAs:17
Drug Master File Entries: see list12
Suppliers / Packaging: see list27
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: levocetirizine dihydrochloride

Clinical Trials for: levocetirizine dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090362-001Jan 31, 2013RXNo<disabled><disabled>
L Perrigo Co
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
SOLUTION;ORAL091263-001Nov 7, 2011RXNo<disabled><disabled>
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 2007RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: levocetirizine dihydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
XYZAL
levocetirizine dihydrochloride
SOLUTION;ORAL022157-001Jan 28, 20085,698,558*PED<disabled>
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 20075,698,558*PED<disabled>
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 20074,525,358<disabled>
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