Application 209089
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | TABLET;ORAL | 5MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 41167-3510 | Xyzal Allergy 24HR | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
| 41167-3510 | Xyzal Allergy 24HR | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |
| 41167-3510 | Xyzal Allergy 24HR | Levocetirizine dihydrochloride | Chattem, Inc. | NDA | Current |