Application 087014
- Type
- ANDA
- Sponsor
- ORGANON USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | No | No |
| 002 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53922 | ORIG | 2018-05-01 |