Application 019835
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | Yes | No |
| 004 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Yes | Yes |
| 005 | ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | Yes | No |
| 006 | ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16853-1305 | ALLEROFF | Cetirizine Hydrochloride | Corporacion Infarmasa | NDA | Current |
| 16853-1307 | ALLEROFF | Cetirizine Hydrochloride | Corporacion Infarmasa | NDA | Current |
| 46084-012 | APTRIZINE | CETIRIZINE HYDROCHLORIDE | A P J Laboratories Limited | ANDA | Current |
| 50269-014 | Zyrtec 1s Blister | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | NDA | Current |
| 50269-014 | Zyrtec 1s Blister | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | NDA | Current |
| 50269-019 | Zyrtec 2s Blister | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | NDA | Current |
| 50269-019 | Zyrtec 2s Blister | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-726 | Zyrtec Allergy | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-752 | Zyrtec Allergy | cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-752 | Zyrtec Allergy | cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-752 | Zyrtec Allergy | cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-752 | Zyrtec Allergy | cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 52904-961 | Zyrtec Allergy | cetirizine hydrochloride | Select Corporation | NDA | Current |
| 63629-2798 | Zyrtec | Cetirizine Hydrochloride | Bryant Ranch Prepack | NDA | Current |
| 67751-192 | Zyrtec Allergy | Cetirizine Hydrochloride | Navajo Manufacturing Company Incorporated | NDA | Current |