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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 020704

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NDA 020704 describes CLARITIN REDITABS, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLARITIN REDITABS profile page.

The generic ingredient in CLARITIN REDITABS is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and fifty suppliers are listed for this compound. Additional details are available on the loratadine profile page.

Summary for 020704

Tradename:	CLARITIN REDITABS
Applicant:	Bayer Healthcare Llc
Ingredient:	loratadine
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020704

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists, Non-Sedating

Suppliers and Packaging for NDA: 020704

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARITIN HIVES RELIEF REDITAB	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704	NDA	Bayer Healthcare LLC.	11523-4329	11523-4329-1	2 CARTON in 1 PACKAGE, COMBINATION (11523-4329-1) / 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLARITIN HIVES RELIEF REDITAB	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704	NDA	Bayer Healthcare LLC.	11523-4329	11523-4329-2	6 BLISTER PACK in 1 CARTON (11523-4329-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Nov 19, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 020704

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002	⤷ Try a Trial	⤷ Try a Trial
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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