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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 076471

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NDA 076471 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 076471

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

Medical Subject Heading (MeSH) Categories for 076471

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

Suppliers and Packaging for NDA: 076471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORATADINE	loratadine	TABLET;ORAL	076471	ANDA	Apotex Corp.	60505-0147	60505-0147-8	1000 TABLET in 1 BOTTLE (60505-0147-8)
LORATADINE	loratadine	TABLET;ORAL	076471	ANDA	Selder, S.A. de C.V.	63654-309	63654-309-10	1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 14, 2006	TE:		RLD:	No

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