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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202936

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NDA 202936 describes DESLORATADINE, which is a drug marketed by Taro, Reddys, Ajenat Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, and Sun Pharm Inds, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the DESLORATADINE profile page.

The generic ingredient in DESLORATADINE is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for 202936

Tradename:	DESLORATADINE
Applicant:	Taro
Ingredient:	desloratadine
Patents:	0

Pharmacology for NDA: 202936

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 202936

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESLORATADINE	desloratadine	SOLUTION;ORAL	202936	ANDA	INA Pharmaceutics, Inc.	74157-011	74157-011-01	118 mL in 1 BOTTLE (74157-011-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.5MG/ML
Approval Date:	May 26, 2016	TE:		RLD:	No

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