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Generated: November 12, 2018

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Details for New Drug Application (NDA): 021952

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NDA 021952 describes CLARITIN, which is a drug marketed by Bayer Healthcare Llc and is included in seven NDAs. It is available from five suppliers. There is one patent protecting this drug. 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 021952
Tradename:CLARITIN
Applicant:Bayer Healthcare Llc
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021952
Suppliers and Packaging for NDA: 021952
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN loratadine CAPSULE;ORAL 021952 NDA Bayer HealthCare LLC. 11523-7200 11523-7200-1 1 BLISTER PACK in 1 CARTON (11523-7200-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
CLARITIN loratadine CAPSULE;ORAL 021952 NDA Bayer HealthCare LLC. 11523-7200 11523-7200-6 3 BLISTER PACK in 1 CARTON (11523-7200-6) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 16, 2008TE:RLD:Yes

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