Application 021909
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | Yes | No |
| 003 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 41167-4232 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4232 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4232 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4232 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4232 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |