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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215127

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NDA 215127 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 215127

Tradename:	LORATADINE
Applicant:	Catalent Pharma
Ingredient:	loratadine
Patents:	0

Medical Subject Heading (MeSH) Categories for 215127

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Feb 28, 2025	TE:		RLD:	No

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