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Generated: May 28, 2017

DrugPatentWatch Database Preview

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 four 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 thirty suppliers are listed for this compound. Additional details are available on the loratadine profile page.

Summary for NDA: 020641

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020641

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength1MG/ML
Approval Date:Nov 27, 2002TE:RLD:Yes
Patent:6,132,758Patent Expiration:Jun 1, 2018Product Flag?YSubstance Flag?Delist Request?

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 020641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc
SYRUP;ORAL020641-002Nov 27, 20024,659,716*PED► Subscribe
Bayer Healthcare Llc
SYRUP;ORAL020641-002Nov 27, 20024,863,931*PED► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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