Details for New Drug Application (NDA): 021165

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NDA 021165 describes CLARINEX, which is a drug marketed by Merck Sharp Dohme, Organon, and Organon Llc, and is included in five NDAs. It is available from one supplier. Additional details are available on the CLARINEX profile page.

The generic ingredient in CLARINEX 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 021165

Tradename:	CLARINEX
Applicant:	Organon
Ingredient:	desloratadine
Patents:	0

Pharmacology for NDA: 021165

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021165

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARINEX	desloratadine	TABLET;ORAL	021165	NDA	Organon LLC	78206-119	78206-119-01	100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01)
CLARINEX	desloratadine	TABLET;ORAL	021165	NDA	Organon LLC	78206-188	78206-188-01	100 TABLET, FILM COATED in 1 BOTTLE (78206-188-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 21, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021165

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	⤷ Sign Up	⤷ Sign Up
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	⤷ Sign Up	⤷ Sign Up
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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