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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076805

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NDA 076805 describes LORATADINE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Catalent Pharma, Marksans Pharma, Onesource Specialty, Sun Pharma Canada, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon Research, Tenshi, Adaptis, Anda Repository, Apotex, Granules, Hetero Labs Ltd V, Mylan, Pharmobedient, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Unique Pharm, Heritage Pharma, and P And L, and is included in forty-six NDAs. It is available from one hundred and fifty-two 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-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Summary for 076805

Tradename:	LORATADINE
Applicant:	Taro
Ingredient:	loratadine
Patents:	0

Medical Subject Heading (MeSH) Categories for 076805

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

Suppliers and Packaging for NDA: 076805

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORATADINE	loratadine	SYRUP;ORAL	076805	ANDA	AmerisourceBergen	24385-531	24385-531-26	1 BOTTLE in 1 CARTON (24385-531-26) / 120 mL in 1 BOTTLE
LORATADINE	loratadine	SYRUP;ORAL	076805	ANDA	AmerisourceBergen	24385-543	24385-543-26	1 BOTTLE in 1 CARTON (24385-543-26) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SYRUP;ORAL			Strength	1MG/ML
Approval Date:	Aug 20, 2004	TE:		RLD:	No

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