Application 016721
- Type
- NDA
- Sponsor
- VALEANT PHARM INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DALMANE | FLURAZEPAM HYDROCHLORIDE | CAPSULE;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | DALMANE | FLURAZEPAM HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43590 | ORIG | 2009-11-18 |
| 10917 | SUPPL | 2009-04-03 |
| 13025 | SUPPL | 2009-04-01 |
| 488 | SUPPL | 2007-11-08 |
| 33195 | SUPPL | 2007-11-07 |
| 44008 | ORIG | 2007-03-16 |
| 487 | SUPPL | 2001-06-14 |