Application 089586
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 1MG | No | No |
| 003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1436 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1437 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1438 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1439 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Sandoz Inc | ANDA | Current |
| 64725-1438 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TYA Pharmaceuticals | ANDA | Current |