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Details for New Drug Application (NDA): 021621

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NDA 021621 describes CHILDREN'S ZYRTEC HIVES RELIEF, which is a drug marketed by J And J Consumer Inc and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CHILDREN'S ZYRTEC HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S ZYRTEC HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 021621

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes
Patent:6,455,533Patent Expiration:Jul 2, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes
Patent:6,455,533Patent Expiration:Jul 2, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS

Summary for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes
Patent:6,455,533Patent Expiration:Jul 2, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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