Details for New Drug Application (NDA): 019670

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NDA 019670 describes CLARITIN-D, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the CLARITIN-D profile page.

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

Summary for 019670

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

Pharmacology for NDA: 019670

Mechanism of Action	Adrenergic alpha-Agonists

Suppliers and Packaging for NDA: 019670

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670	NDA	Bayer HealthCare LLC.	11523-7162	11523-7162-1	1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670	NDA	Bayer HealthCare LLC.	11523-7162	11523-7162-2	2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;120MG
Approval Date:	Nov 27, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 019670

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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