Application 021150
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | ZYRTEC-D 12 HOUR | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50580-728 | ZYRTEC-D | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-728 | ZYRTEC-D | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-728 | ZYRTEC-D | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-728 | ZYRTEC-D | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79606 | SUPPL | 2024-09-16 |
| 79605 | SUPPL | 2024-09-16 |
| 69330 | SUPPL | 2021-11-16 |
| 69236 | SUPPL | 2021-11-05 |
| 21478 | SUPPL | 2008-05-21 |
| 26910 | SUPPL | 2007-11-13 |
| 14507 | SUPPL | 2004-04-05 |
| 4474 | SUPPL | 2004-03-24 |
| 4473 | SUPPL | 2003-05-29 |
| 14506 | SUPPL | 2003-04-17 |
| 41986 | ORIG | 2001-08-10 |
| 26909 | ORIG | 2001-08-10 |
| 14505 | ORIG | 2001-08-10 |