Application 091327
- Type
- ANDA
- Sponsor
- ATHEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
| 002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57664-246 | Cetirizine Hydrochloride HIVES | Cetirizine Hydrochloride | Caraco Pharmaceutical Laboratories, Ltd | ANDA | Current |
| 57664-263 | CETIRIZINE HYDROLORIDE Allergy | CETIRIZINE HYDROLORIDE | Caraco Pharmaceutical Laboratories, Ltd | ANDA | Current |