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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 020641

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NDA 020641 describes CLARITIN HIVES RELIEF, which is a drug marketed by Bayer Healthcare Llc and is included in three NDAs. It is available from six suppliers. Additional details are available on the CLARITIN HIVES RELIEF profile page.

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

Summary for 020641

Tradename:	CLARITIN HIVES RELIEF
Applicant:	Bayer Healthcare Llc
Ingredient:	loratadine
Patents:	0

Medical Subject Heading (MeSH) Categories for 020641

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

Suppliers and Packaging for NDA: 020641

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARITIN	loratadine	SYRUP;ORAL	020641	NDA	Bayer HealthCare LLC.	11523-0101	11523-0101-1	1 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE
CLARITIN	loratadine	SYRUP;ORAL	020641	NDA	Bayer HealthCare LLC.	11523-0101	11523-0101-2	1 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLE

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SYRUP;ORAL			Strength	1MG/ML
Approval Date:	Nov 27, 2002	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 19, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 020641

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	4,659,716*PED	⤷ Get Started Free
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	6,132,758	⤷ Get Started Free
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	4,863,931*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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