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Generated: May 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021891

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NDA 021891 describes CLARITIN, which is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs. It is available from five suppliers. Additional details are available on the CLARITIN profile page.

The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 021891
Tradename:CLARITIN
Applicant:Bayer Healthcare Llc
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021891
Suppliers and Packaging for NDA: 021891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CLARITIN loratadine TABLET, CHEWABLE;ORAL 021891 NDA Bayer HealthCare LLC. 11523-4328 11523-4328-1 1 BLISTER PACK in 1 CARTON (11523-4328-1) > 10 TABLET, CHEWABLE in 1 BLISTER PACK
CHILDREN'S CLARITIN loratadine TABLET, CHEWABLE;ORAL 021891 NDA Bayer HealthCare LLC. 11523-4328 11523-4328-2 2 BLISTER PACK in 1 CARTON (11523-4328-2) > 10 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Aug 23, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Nov 21, 2018TE:RLD:Yes

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