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Details for New Drug Application (NDA): 075790

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NDA 075790 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, and Actavis Labs Fl Inc, and is included in twenty-seven NDAs. It is available from one hundred and fourteen 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: 075790

Tradename:
LORATADINE
Applicant:
Mylan
Ingredient:
loratadine
Patents:0
Formulation / Manufacturing:see details

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

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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