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Generated: November 18, 2018

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Details for New Drug Application (NDA): 021891

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NDA 021891 describes CHILDREN'S CLARITIN, which is a drug marketed by Bayer Healthcare Llc and is included in one NDA. It is available from one supplier. Additional details are available on the CHILDREN'S CLARITIN profile page.

The generic ingredient in CHILDREN'S CLARITIN 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 021891
Tradename:CHILDREN'S 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

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