Application 091476
- Type
- ANDA
- Sponsor
- ANCHEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10370-175 | Fluvoxamine Maleate | Fluvoxamine Maleate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-175 | Fluvoxamine Maleate | Fluvoxamine Maleate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-175 | Fluvoxamine Maleate | Fluvoxamine Maleate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-176 | Fluvoxamine Maleate | Fluvoxamine Maleate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-176 | Fluvoxamine Maleate | Fluvoxamine Maleate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-176 | Fluvoxamine Maleate | Fluvoxamine Maleate | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9340 | ORIG | 2013-03-15 |