Application 020966
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPORANOX | ITRACONAZOLE | INJECTABLE;INJECTION | 10MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13825 | SUPPL | 2009-04-28 |
| 3863 | SUPPL | 2009-04-27 |
| 35730 | SUPPL | 2009-04-03 |
| 35729 | SUPPL | 2009-04-03 |
| 13824 | SUPPL | 2009-04-03 |
| 26308 | SUPPL | 2009-03-10 |
| 26307 | SUPPL | 2009-03-10 |
| 3862 | SUPPL | 2009-03-10 |
| 35728 | SUPPL | 2004-07-21 |
| 3861 | SUPPL | 2004-07-21 |
| 41844 | ORIG | 2003-08-13 |
| 35727 | SUPPL | 2002-07-17 |
| 3860 | SUPPL | 2002-07-17 |
| 26306 | SUPPL | 2002-02-28 |
| 41845 | SUPPL | 2001-10-26 |
| 21306 | SUPPL | 2001-10-26 |
| 21305 | SUPPL | 2001-10-26 |
| 35726 | SUPPL | 2001-04-17 |
| 35725 | SUPPL | 2001-04-17 |
| 26305 | SUPPL | 2001-04-17 |
| 13823 | SUPPL | 2001-04-17 |
| 3859 | SUPPL | 2001-04-17 |
| 3858 | SUPPL | 2001-04-17 |
| 13822 | ORIG | 1999-03-30 |
| 3857 | ORIG | 1999-03-30 |