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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 210409


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NDA 210409 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, Anda Repository, Apotex Inc, Granules, 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 210409
Tradename:LORATADINE
Applicant:Hetero Labs Ltd Iii
Ingredient:loratadine
Patents:0
Medical Subject Heading (MeSH) Categories for 210409
Suppliers and Packaging for NDA: 210409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine SYRUP;ORAL 210409 ANDA Camber Consumer Care Inc 69230-322 69230-322-12 1 BOTTLE in 1 CARTON (69230-322-12) / 120 mL in 1 BOTTLE
LORATADINE loratadine SYRUP;ORAL 210409 ANDA Camber Consumer Care Inc 69230-322 69230-322-24 1 BOTTLE in 1 CARTON (69230-322-24) / 240 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength1MG/ML
Approval Date:May 7, 2021TE:RLD:No

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