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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 075209


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NDA 075209 describes LORATADINE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Marksans Pharma, Strides Pharma, Taro, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon, Tenshi, Apotex Inc, Granules, Guardian Drug, Hetero Labs Ltd V, Mylan, Norvium Bioscience, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Unique Pharm, Heritage Pharma, and P And L, and is included in forty-four NDAs. It is available from one hundred and fifty 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. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 075209
Tradename:LORATADINE
Applicant:Pld Acquisitions Llc
Ingredient:loratadine
Patents:0
Medical Subject Heading (MeSH) Categories for 075209
Suppliers and Packaging for NDA: 075209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine TABLET;ORAL 075209 ANDA Walgreens 0363-0858 0363-0858-03 1 BOTTLE, PLASTIC in 1 BOX (0363-0858-03) / 30 TABLET in 1 BOTTLE, PLASTIC
LORATADINE loratadine TABLET;ORAL 075209 ANDA Walgreens 0363-0858 0363-0858-05 5 BLISTER PACK in 1 CARTON (0363-0858-05) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jan 21, 2003TE:RLD:No

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