Application 020038
- Type
- NDA
- Sponsor
- GENZYME CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUDARA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 1948 | SUPPL | 2010-08-02 |
| 34207 | SUPPL | 2010-07-31 |
| 1947 | SUPPL | 2009-02-13 |
| 34206 | SUPPL | 2009-02-12 |
| 21073 | SUPPL | 2008-01-09 |
| 12160 | SUPPL | 2007-12-27 |
| 34205 | SUPPL | 2003-08-14 |
| 1946 | SUPPL | 2003-08-14 |
| 34204 | SUPPL | 2003-04-21 |
| 63714 | SUPPL | 1900-01-01 |
| 63713 | SUPPL | 1900-01-01 |
| 51947 | ORIG | 1900-01-01 |
| 51946 | ORIG | 1900-01-01 |