Application 022578
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022578-001 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | a1edc2e6-3661-4d7a-884c-709d73cb89e0 | 2025-04-22 | Warnings | 022578 NDA022578 50580-782 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 2025-04-11 | Warnings | 022578 NDA022578 50580-778 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |