Application 078398
- Type
- ANDA
- Sponsor
- PERRIGO PHARMS CO
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-878 | Cetirizine | Cetirizine | Rebel Distributors Corp | ANDA | Current |
| 45802-626 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Perrigo New York Inc | ANDA | Current |
| 45802-626 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Perrigo New York Inc | ANDA | Current |
| 45802-626 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 50090-4288 | Cetirizine Hydrochloride | Cetirizine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4288 | Cetirizine Hydrochloride | Cetirizine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 63629-2521 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2521 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2521 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68151-1008 | Cetirizine Hydrochloride | Cetirizine hydrochloride | Carilion Materials Management | ANDA | Current |