Application 090279
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 2MG BASE | No | No |
| 002 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 8MG BASE | No | No |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|---|---|---|---|
| 24067 | REMS | ORIG | 1 | 2015-07-02 |