Application 078862
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-271 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Northstar Rx LLC | ANDA | Current |
| 16714-271 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Northstar Rx LLC | ANDA | Current |
| 49348-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | McKesson | ANDA | Current |
| 66116-417 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | MedVantx, Inc. | ANDA | Current |