Details for New Drug Application (NDA): 021313

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NDA 021313 describes CLARINEX-D 12 HOUR, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. Additional details are available on the CLARINEX-D 12 HOUR profile page.

The generic ingredient in CLARINEX-D 12 HOUR 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 021313

Tradename:	CLARINEX-D 12 HOUR
Applicant:	Organon Llc
Ingredient:	desloratadine; pseudoephedrine sulfate
Patents:	0

Pharmacology for NDA: 021313

Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021313

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313	NDA	Organon LLC	78206-120	78206-120-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	2.5MG;120MG
Approval Date:	Feb 1, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021313

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	⤷ Sign Up	⤷ Sign Up
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	⤷ Sign Up	⤷ Sign Up
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	⤷ Sign Up	⤷ Sign Up
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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