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Generated: November 18, 2018

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Details for New Drug Application (NDA): 021993

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NDA 021993 describes CLARITIN REDITABS, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the CLARITIN REDITABS profile page.

The generic ingredient in CLARITIN REDITABS 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 021993
Tradename:CLARITIN REDITABS
Applicant:Bayer Healthcare Llc
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021993
Suppliers and Packaging for NDA: 021993
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 021993 NDA Bayer HealthCare LLC 11523-7202 11523-7202-1 3 BLISTER PACK in 1 CARTON (11523-7202-1) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 021993 NDA Bayer HealthCare LLC 11523-7202 11523-7202-3 1 BLISTER PACK in 1 CARTON (11523-7202-3) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Dec 12, 2006TE:RLD:Yes

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