Details for New Drug Application (NDA): 020470

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NDA 020470 describes CLARITIN-D 24 HOUR, which is a drug marketed by Bayer Healthcare Llc and is included in one NDA. It is available from one supplier. Additional details are available on the CLARITIN-D 24 HOUR profile page.

The generic ingredient in CLARITIN-D 24 HOUR is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Summary for 020470

Tradename:	CLARITIN-D 24 HOUR
Applicant:	Bayer Healthcare Llc
Ingredient:	loratadine; pseudoephedrine sulfate
Patents:	0

Pharmacology for NDA: 020470

Mechanism of Action	Adrenergic alpha-Agonists

Suppliers and Packaging for NDA: 020470

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332	11523-4332-1	1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332	11523-4332-2	1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG;240MG
Approval Date:	Nov 27, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 020470

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	4,659,716*PED	⤷ Subscribe
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	5,314,697*PED	⤷ Subscribe
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	4,863,931*PED	⤷ Subscribe
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