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Serving 500+ biopharmaceutical companies globally:

Novartis
Healthtrust
Federal Trade Commission
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Colorcon
Julphar
Fish and Richardson
Moodys
Dow
Express Scripts

Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076134

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NDA 076134 describes LORATADINE, which is a drug marketed by Perrigo, Taro, Teva, Sandoz, Perrigo Pharma Intl, Marksans Pharma, Wockhardt, Silarx, Pfizer, Ranbaxy Labs Ltd, Sun Pharm Inds Ltd, Mylan, Apotex Inc, Taro Pharm, and Actavis Labs Fl Inc, and is included in twenty-seven NDAs. It is available from one hundred and twenty-one 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-seven suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Summary for NDA: 076134

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076134

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE
loratadine
TABLET;ORAL 076134 ANDA Kaiser Foundation Hospitals 0179-8317 0179-8317-01 1 BOTTLE in 1 CARTON (0179-8317-01) > 100 TABLET in 1 BOTTLE
LORATADINE
loratadine
TABLET;ORAL 076134 ANDA Kaiser Foundation Hospitals 0179-8317 0179-8317-30 1 BOTTLE in 1 CARTON (0179-8317-30) > 30 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Aug 18, 2003TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Cantor Fitzgerald
Baxter
Chubb
Harvard Business School
Cipla
UBS
Boehringer Ingelheim
Citi

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