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Application 211415
- Type
- NDA
- Sponsor
- JDP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QUZYTTIR | CETIRIZINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/ML (10MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70720-100 | QUZYTTIR | Cetirizine Hydrochloride | TerSera Therapeutics LLC | NDA | Current |
| 70720-100 | QUZYTTIR | Cetirizine Hydrochloride | TerSera Therapeutics LLC | NDA | Current |
| 70720-100 | QUZYTTIR | Cetirizine Hydrochloride | TerSera Therapeutics LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82981 | SUPPL | 2025-07-29 |
| 82967 | SUPPL | 2025-07-29 |
| 62456 | ORIG | 2020-04-06 |
| 61089 | SUPPL | 2019-11-29 |
| 60264 | ORIG | 2019-10-07 |
| 60255 | ORIG | 2019-10-07 |
| 62903 | ORIG | 1900-01-01 |