Application 010485
- Type
- NDA
- Sponsor
- ROERIG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATARAX | HYDROXYZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 11903 | SUPPL | 2001-03-21 |