Application 217410
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 1MG | No | No |
| 002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-252 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-253 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-254 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-255 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |