Application 075893
- Type
- ANDA
- Sponsor
- TEVA
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 |
|---|---|---|---|---|---|
| 0615-7569 | Fluvoxamine Maleate | Fluvoxamine Maleate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44275 | ORIG | 2007-05-09 |