Application 022157
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | SOLUTION;ORAL | 2.5MG/5ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0024-5804 | Xyzal | levocetirizine dihydrochloride | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5804 | Xyzal | levocetirizine dihydrochloride | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5804 | Xyzal | levocetirizine dihydrochloride | Sanofi-Aventis U.S. LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82833 | SUPPL | 2025-07-14 |
| 82829 | SUPPL | 2025-07-14 |
| 58215 | SUPPL | 2019-04-04 |
| 58196 | SUPPL | 2019-04-03 |
| 57255 | SUPPL | 2019-01-18 |
| 57233 | SUPPL | 2019-01-16 |
| 53594 | SUPPL | 2018-04-03 |
| 53593 | SUPPL | 2018-04-03 |
| 50109 | SUPPL | 2017-10-19 |
| 50064 | SUPPL | 2017-10-17 |
| 48969 | SUPPL | 2017-07-13 |
| 48964 | SUPPL | 2017-07-13 |
| 47235 | SUPPL | 2017-02-16 |
| 47167 | SUPPL | 2017-02-10 |
| 45860 | SUPPL | 2016-11-09 |
| 45857 | SUPPL | 2016-11-09 |
| 17033 | SUPPL | 2016-06-27 |
| 29337 | SUPPL | 2016-06-24 |
| 17032 | SUPPL | 2013-11-08 |
| 6984 | SUPPL | 2013-11-08 |
| 38317 | SUPPL | 2012-09-11 |
| 29336 | SUPPL | 2012-09-07 |
| 6983 | SUPPL | 2011-03-10 |
| 17031 | SUPPL | 2011-03-07 |
| 44687 | ORIG | 2010-04-01 |
| 42433 | ORIG | 2010-04-01 |
| 6982 | SUPPL | 2009-11-10 |
| 17030 | SUPPL | 2009-10-06 |
| 17029 | SUPPL | 2008-06-30 |
| 6981 | SUPPL | 2008-06-30 |
| 29335 | ORIG | 2008-01-30 |
| 17028 | ORIG | 2008-01-30 |
| 53313 | ORIG | 1900-01-01 |
| 53312 | ORIG | 1900-01-01 |