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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Queensland Health
Cerilliant
Colorcon
Mallinckrodt
Chinese Patent Office
UBS
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075790

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NDA 075790 describes LORATADINE, which is a drug marketed by Marksans Pharma, Taro, Apotex Inc, Perrigo, Ranbaxy Labs Ltd, Silarx, Taro Pharm, Teva, Wockhardt, Actavis Labs Fl Inc, Perrigo Pharma Intl, Pfizer, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty-seven NDAs. It is available from one hundred and twenty-five suppliers. Additional details are available on the LORATADINE profile page.

The generic ingredient in LORATADINE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 075790
Tradename:LORATADINE
Applicant:Mylan
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075790
Suppliers and Packaging for NDA: 075790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine TABLET;ORAL 075790 ANDA Cardinal Health 55154-5099 55154-5099-0 10 BLISTER PACK in 1 BAG (55154-5099-0) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Nov 7, 2008TE:RLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
Novartis
Queensland Health
Argus Health
Colorcon
Fuji
Boehringer Ingelheim
Daiichi Sankyo
Chubb

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