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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 one supplier. 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 forty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride 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 forty-one 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 ALLERGY | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 021621 | 2005-03-25 |
| CHILDREN'S ZYRTEC HIVES RELIEF | 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Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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 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 |
| J And J Consumer Inc | CHILDREN'S ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-005 | Nov 16, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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