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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076301


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NDA 076301 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, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Unique Pharm, Heritage Pharma, and P And L, and is included in forty-three NDAs. It is available from one hundred and forty-three 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-five suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 076301
Tradename:LORATADINE
Applicant:Perrigo
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076301
Suppliers and Packaging for NDA: 076301
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine TABLET;ORAL 076301 ANDA L. Perrigo Company 0113-0612 0113-0612-39 30 BLISTER PACK in 1 CARTON (0113-0612-39) / 1 TABLET in 1 BLISTER PACK
LORATADINE loratadine TABLET;ORAL 076301 ANDA L. Perrigo Company 0113-0612 0113-0612-46 10 BLISTER PACK in 1 CARTON (0113-0612-46) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jun 25, 2004TE:RLD:No

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