Application 022578
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50580-778 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-778 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-778 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-782 | Childrens Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-782 | Childrens Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-782 | Childrens Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-782 | Childrens Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80236 | SUPPL | 2024-11-19 |
| 80235 | SUPPL | 2024-11-19 |
| 45229 | SUPPL | 2016-08-23 |
| 45176 | SUPPL | 2016-08-23 |
| 7566 | SUPPL | 2011-12-05 |
| 44784 | ORIG | 2011-02-17 |
| 22065 | ORIG | 2011-01-25 |
| 29883 | ORIG | 2010-09-08 |