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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 020704


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NDA 020704 describes CLARITIN REDITABS, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from two suppliers. 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 fifty-five suppliers are listed for this compound. Additional details are available on the loratadine profile page.
Summary for 020704
Tradename:CLARITIN REDITABS
Applicant:Bayer Healthcare Llc
Ingredient:loratadine
Patents:0
Medical Subject Heading (MeSH) Categories for 020704
Suppliers and Packaging for NDA: 020704
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN HIVES RELIEF REDITAB loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704 NDA Bayer Healthcare LLC. 11523-4329 11523-4329-1 2 CARTON in 1 PACKAGE, COMBINATION (11523-4329-1) / 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLARITIN HIVES RELIEF REDITAB loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704 NDA Bayer Healthcare LLC. 11523-4329 11523-4329-2 6 BLISTER PACK in 1 CARTON (11523-4329-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 020704

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002 ⤷  Sign Up ⤷  Sign Up
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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