Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220448

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NDA 220448 describes LORATADINE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Bionpharma, Dr Reddys, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in seven NDAs. It is available from thirty suppliers. Additional details are available on the LORATADINE AND PSEUDOEPHEDRINE SULFATE profile page.

The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Summary for 220448

Tradename:	LORATADINE AND PSEUDOEPHEDRINE SULFATE
Applicant:	Dr Reddys
Ingredient:	loratadine; pseudoephedrine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;120MG
Approval Date:	Aug 6, 2026	TE:		RLD:	No

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