Application 015539
- Type
- NDA
- Sponsor
- ALPHARMA US PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | SERAX | OXAZEPAM | CAPSULE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 004 | SERAX | OXAZEPAM | CAPSULE;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 006 | SERAX | OXAZEPAM | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 008 | SERAX | OXAZEPAM | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10860 | SUPPL | 2001-08-08 |
| 401 | SUPPL | 2001-08-08 |