Application 021621
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50580-753 | Zyrtec | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |