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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076529

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NDA 076529 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: 076529

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

Pharmacology for NDA: 076529

Suppliers and Packaging for NDA: 076529

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE
loratadine
SYRUP;ORAL 076529 ANDA Rebel Distributors Corp 21695-822 21695-822-30 30 CAPSULE in 1 BOTTLE (21695-822-30)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength1MG/ML
Approval Date:Aug 20, 2004TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
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Deloitte

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