Application 019297
- Type
- NDA
- Sponsor
- EMD SERONO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOVANTRONE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | Yes | No |
| 002 | NOVANTRONE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | NOVANTRONE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43618 | SUPPL | 2012-03-27 |
| 11472 | SUPPL | 2012-03-27 |
| 17353 | SUPPL | 2012-03-26 |
| 33719 | SUPPL | 2010-06-24 |
| 11471 | SUPPL | 2010-06-24 |
| 17352 | SUPPL | 2010-06-16 |
| 1278 | SUPPL | 2010-06-16 |
| 17351 | SUPPL | 2009-02-13 |
| 1277 | SUPPL | 2009-02-13 |
| 33718 | SUPPL | 2009-02-12 |
| 11470 | SUPPL | 2009-02-12 |
| 23548 | ORIG | 2008-07-29 |
| 40884 | ORIG | 2008-04-04 |
| 1276 | SUPPL | 2007-04-20 |
| 11469 | SUPPL | 2005-04-28 |
| 1275 | SUPPL | 2005-04-28 |
| 17350 | SUPPL | 2003-01-13 |
| 1274 | SUPPL | 2003-01-13 |
| 1273 | SUPPL | 2003-01-13 |
| 1272 | SUPPL | 2002-02-20 |
| 40886 | SUPPL | 2000-02-04 |
| 40885 | SUPPL | 1997-11-20 |