Application 075900
- Type
- ANDA
- Sponsor
- ECI PHARMS LLC
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 |
|---|---|---|---|---|---|
| 57664-357 | FLUVOXAMINE MALEATE | fluvoxamine maleate | Caraco Pharmaceutical Laboratories, Ltd. | ANDA | Current |
| 57664-361 | FLUVOXAMINE MALEATE | fluvoxamine maleate | Caraco Pharmaceutical Laboratories, Ltd. | ANDA | Current |
| 57664-362 | FLUVOXAMINE MALEATE | fluvoxamine maleate | Caraco Pharmaceutical Laboratories, Ltd. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44278 | ORIG | 2006-03-02 |