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Serving leading biopharmaceutical companies globally:

McKinsey
Chubb
Deloitte
Cipla
Healthtrust
Moodys
Merck
Queensland Health
Express Scripts
Farmers Insurance

Generated: December 11, 2017

DrugPatentWatch Database Preview

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 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 thirty-one suppliers are listed for this compound. Additional details are available on the loratadine profile page.

Summary for 020704

Tradename:2
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020704

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare LlcCLARITIN REDITABSloratadineTABLET, ORALLY DISINTEGRATING;ORAL020704-002Nov 27, 2002► Subscribe► Subscribe
Bayer Healthcare LlcCLARITIN REDITABSloratadineTABLET, ORALLY DISINTEGRATING;ORAL020704-002Nov 27, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army
Healthtrust
Harvard Business School
Federal Trade Commission
Mallinckrodt
Daiichi Sankyo
Boehringer Ingelheim
Covington
Medtronic
Argus Health

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