Application 091567
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 003 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
| 006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51660-998 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | OHM LABORATORIES INC. | ANDA | Current |
| 62756-542 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-542 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-543 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-543 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-545 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-545 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-545 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |