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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076134

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NDA 076134 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 076134

Tradename:	LORATADINE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	loratadine
Patents:	0

Medical Subject Heading (MeSH) Categories for 076134

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

Suppliers and Packaging for NDA: 076134

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORATADINE	loratadine	TABLET;ORAL	076134	ANDA	Marlex Pharmaceuticals, Inc.	10135-763	10135-763-03	300 TABLET in 1 BOTTLE (10135-763-03)
LORATADINE	loratadine	TABLET;ORAL	076134	ANDA	Marlex Pharmaceuticals, Inc.	10135-763	10135-763-30	30 TABLET in 1 BOTTLE (10135-763-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 18, 2003	TE:		RLD:	No

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