Application 209090
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | SOLUTION;ORAL | 2.5MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 41167-3530 | Childrens Xyzal Allergy | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
| 41167-3530 | Childrens Xyzal Allergy | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
| 41167-3530 | Childrens Xyzal Allergy | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
| 41167-3530 | Childrens Xyzal Allergy | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
| 41167-3530 | Childrens Xyzal Allergy | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85290 | SUPPL | 2026-03-09 |
| 82910 | SUPPL | 2025-07-23 |
| 82909 | SUPPL | 2025-07-23 |
| 72505 | SUPPL | 2022-10-31 |
| 72502 | SUPPL | 2022-10-31 |
| 71553 | SUPPL | 2022-07-14 |
| 71551 | SUPPL | 2022-07-14 |
| 67016 | SUPPL | 2021-04-09 |
| 65199 | SUPPL | 2020-11-12 |
| 49022 | ORIG | 2017-07-20 |
| 47068 | ORIG | 2017-01-31 |
| 47066 | ORIG | 2017-01-31 |