Application 212182
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 002 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69452-182 | Fluvoxamine Maleate | Fluvoxamine Maleate | Bionpharma Inc. | ANDA | Current |
| 69452-183 | Fluvoxamine Maleate | Fluvoxamine Maleate | Bionpharma Inc. | ANDA | Current |
| 69452-183 | Fluvoxamine Maleate | Fluvoxamine Maleate | Bionpharma Inc. | ANDA | Current |