Application 075902
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | TABLET;ORAL | 25MG | No | No |
| 002 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | TABLET;ORAL | 50MG | No | No |
| 003 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50268-340 | Fluvoxamine Maleate | Fluvoxamine Maleate | AvPAK | ANDA | Current |
| 50268-341 | Fluvoxamine Maleate | Fluvoxamine Maleate | AvPAK | ANDA | Current |
| 50268-342 | Fluvoxamine Maleate | Fluvoxamine Maleate | AvPAK | ANDA | Current |
| 60505-0164 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0164 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0164 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0164 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0164 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0165 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0165 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0165 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0165 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0165 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0166 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0166 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0166 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0166 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 60505-0166 | Fluvoxamine Maleate | Fluvoxamine Maleate | Apotex Corp | ANDA | Current |
| 68788-8175 | Fluvoxamine Maleate | Fluvoxamine Maleate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-1974 | Fluvoxamine Maleate | Fluvoxamine Maleate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1974 | Fluvoxamine Maleate | Fluvoxamine Maleate | Bryant Ranch Prepack | ANDA | Current |
| 71335-2008 | Fluvoxamine Maleate | Fluvoxamine Maleate | Bryant Ranch Prepack | ANDA | Current |
| 72789-221 | Fluvoxamine Maleate | Fluvoxamine Maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |