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Last Updated: December 12, 2019

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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 forty-five 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020641
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. 11523-4360 11523-4360-1 1 BOTTLE in 1 CARTON (11523-4360-1) > 60 mL in 1 BOTTLE
CLARITIN loratadine SYRUP;ORAL 020641 NDA Bayer HealthCare LLC. 11523-4360 11523-4360-2 1 BOTTLE in 1 CARTON (11523-4360-2) > 120 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 020641
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN SYRUP;ORAL loratadine 020641
CLARITIN HIVES RELIEF SYRUP;ORAL loratadine 020641

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength1MG/ML
Approval Date:Nov 27, 2002TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 19, 2003TE:RLD:Yes

Expired US Patents for NDA 020641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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