Application 017391
- Type
- NDA
- Sponsor
- CASPER PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMURAN | AZATHIOPRINE SODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79049 | SUPPL | 2024-07-11 |
| 79033 | SUPPL | 2024-07-10 |
| 57003 | SUPPL | 2018-12-21 |
| 56944 | SUPPL | 2018-12-21 |
| 13128 | SUPPL | 2014-02-11 |
| 33259 | SUPPL | 2014-02-07 |
| 13127 | SUPPL | 2011-05-26 |
| 33258 | SUPPL | 2011-05-25 |
| 575 | SUPPL | 2008-07-14 |
| 10981 | SUPPL | 2008-07-10 |
| 10980 | SUPPL | 2005-07-29 |
| 574 | SUPPL | 2005-07-29 |
| 573 | SUPPL | 2003-07-24 |