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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Farmers Insurance
Citi
Healthtrust
US Department of Justice
Argus Health
Mallinckrodt
Novartis
Teva

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201865

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NDA 201865 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 201865
Tradename:LORATADINE
Applicant:Taro Pharm
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201865
Suppliers and Packaging for NDA: 201865
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine SYRUP;ORAL 201865 ANDA Walgreen Company 0363-2108 0363-2108-08 1 BOTTLE in 1 CARTON (0363-2108-08) > 120 mL in 1 BOTTLE
LORATADINE loratadine SYRUP;ORAL 201865 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-2108 51672-2108-8 1 BOTTLE in 1 CARTON (51672-2108-8) > 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength1MG/ML
Approval Date:Jul 31, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
QuintilesIMS
Chinese Patent Office
Mallinckrodt
Cerilliant
Daiichi Sankyo
US Army
Fuji

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