Levocetirizine dihydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, L Perrigo Co, Taro Pharm Inds, Ucb Inc, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Micro Labs Ltd India, Sandoz, Sciegen Pharms Inc, Sun Pharma Global, Synthon Pharms, and Teva Pharms, and is included in fourteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are twelve drug master file entries for levocetirizine dihydrochloride. Six suppliers are listed for this compound.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|TABLET;ORAL||090385||Feb 24, 2011||RX||No||<disabled>||<disabled>|
|TABLET;ORAL||090199||Aug 22, 2011||RX||No||<disabled>||<disabled>|
Sun Pharma Global
|TABLET;ORAL||090362||Jan 31, 2013||RX||No||<disabled>||<disabled>|
|SOLUTION;ORAL||202915||Aug 21, 2014||RX||No||<disabled>||<disabled>|
|TABLET;ORAL||022064||May 25, 2007||RX||Yes||5,698,558*PED||<disabled>||Y||<disabled>|
|This preview shows a limited data set|
Subscribe for full access, or try a free trial
Export unavailable in trial.
Subscribe for complete access.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.