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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 019658

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NDA 019658 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 sixteen suppliers are listed for this compound. Additional details are available on the loratadine profile page.
Summary for 019658
Applicant:Bayer Healthcare Llc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019658
Suppliers and Packaging for NDA: 019658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN loratadine TABLET;ORAL 019658 NDA Bayer HealthCare LLC. 11523-1527 11523-1527-1 50 POUCH in 1 BOX (11523-1527-1) > 1 TABLET in 1 POUCH
CLARITIN loratadine TABLET;ORAL 019658 NDA Bayer HealthCare LLC. 11523-1527 11523-1527-2 50 POUCH in 1 BOX (11523-1527-2) > 1 TABLET in 1 POUCH
Paragraph IV (Patent) Challenges for 019658
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN TABLET;ORAL loratadine 019658

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Nov 27, 2002TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Nov 19, 2003TE:RLD:Yes

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