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Serving leading biopharmaceutical companies globally:

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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076154

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NDA 076154 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 076154
Tradename:LORATADINE
Applicant:Mylan
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076154
Suppliers and Packaging for NDA: 076154
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine TABLET;ORAL 076154 ANDA Mylan Pharmaceuticals Inc. 0378-8880 0378-8880-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)
LORATADINE loratadine TABLET;ORAL 076154 ANDA Mylan Institutional Inc. 51079-246 51079-246-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-246-20) > 1 TABLET in 1 BLISTER PACK (51079-246-01)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Aug 20, 2003TE:RLD:No

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