Application 208123
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | No | No |
| 002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51672-2119 | Childrens Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-2121 | Childrens Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |