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Details for New Drug Application (NDA): 021621
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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 thirty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 021621
Tradename: | CHILDREN'S ZYRTEC HIVES RELIEF |
Applicant: | J And J Consumer Inc |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 021621
Paragraph IV (Patent) Challenges for 021621
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
CHILDREN'S ZYRTEC HIVES RELIEF | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 021621 | 2005-03-25 |
CHILDREN'S ZYRTEC ALLERGY | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 021621 | 2005-03-25 |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes |
Expired US Patents for NDA 021621
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | CHILDREN'S ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-005 | Nov 16, 2007 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-003 | Nov 16, 2007 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-004 | Nov 16, 2007 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-006 | Nov 16, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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