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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 five 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 twenty-three suppliers are listed for this compound. Additional details are available on the loratadine profile page.

Summary for NDA: 020641

Bayer Healthcare Llc

Suppliers and Packaging for NDA: 020641

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYRUP;ORAL 020641 NDA MSD Consumer Care, Inc. 11523-4360 11523-4360-2 1 BOTTLE in 1 CARTON (11523-4360-2) > 120 mL in 1 BOTTLE
SYRUP;ORAL 020641 NDA MSD Consumer Care, Inc. 11523-4360 11523-4360-4 1 BOTTLE in 1 CARTON (11523-4360-4) > 30 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Expired Orange Book Patents for NDA: 020641

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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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