FdaApplication
NDA 021621
Identifiers
- fda_app_no: NDA021621
Properties
| Property | Value |
|---|---|
| applicant_name | KENVUE BRANDS LLC |
| application_type | NDA |
| approval_date | 2007-11-16 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL |
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
| CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
| CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
5 products