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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212795

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NDA 212795 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 212795

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

Medical Subject Heading (MeSH) Categories for 212795

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

Suppliers and Packaging for NDA: 212795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORATADINE	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	212795	ANDA	Walgreens Company	0363-9955	0363-9955-30	3 BLISTER PACK in 1 CARTON (0363-9955-30) / 10 TABLET in 1 BLISTER PACK
LORATADINE	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	212795	ANDA	Dr. Reddy's Laboratories Inc.	43598-756	43598-756-10	1 BLISTER PACK in 1 CARTON (43598-756-10) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	5MG
Approval Date:	Sep 18, 2020	TE:		RLD:	No

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