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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213294


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NDA 213294 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 213294
Tradename:LORATADINE
Applicant:Tenshi
Ingredient:loratadine
Patents:0
Medical Subject Heading (MeSH) Categories for 213294
Suppliers and Packaging for NDA: 213294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 213294 ANDA Dr. Reddy's Laboratories Inc. 43598-707 43598-707-30 3 BLISTER PACK in 1 CARTON (43598-707-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
LORATADINE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 213294 ANDA Dr. Reddy's Laboratories Inc. 43598-758 43598-758-10 1 BLISTER PACK in 1 CARTON (43598-758-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Oct 30, 2020TE:RLD:No

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