Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021621

Expand all

CHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 003
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Discontinued
Patent and Exclusivity Information

CHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 004
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Discontinued
Patent and Exclusivity Information

CHILDREN'S ZYRTEC HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 005
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Discontinued
Patent and Exclusivity Information

CHILDREN'S ZYRTEC HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 006
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Discontinued
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English