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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 207569

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NDA 207569 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 207569

Tradename:	LORATADINE
Applicant:	Guardian Drug
Ingredient:	loratadine
Patents:	0

Medical Subject Heading (MeSH) Categories for 207569

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists, Non-Sedating

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 12, 2019	TE:		RLD:	No

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