Application 020083
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPORANOX | ITRACONAZOLE | CAPSULE;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10147-1700 | itraconazole | ITRACONAZOLE | Patriot Pharmaceuticals | NDA | Current |
| 10147-1700 | itraconazole | ITRACONAZOLE | Patriot Pharmaceuticals | NDA | Current |
| 10147-1700 | itraconazole | ITRACONAZOLE | Patriot Pharmaceuticals | NDA | Current |
| 10147-1700 | itraconazole | ITRACONAZOLE | Patriot Pharmaceuticals | NDA | Current |
| 10147-1700 | itraconazole | ITRACONAZOLE | Patriot Pharmaceuticals | NDA | Current |
| 10147-1700 | itraconazole | ITRACONAZOLE | Patriot Pharmaceuticals | NDA | Current |
| 50458-290 | SPORANOX | ITRACONAZOLE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-290 | SPORANOX | ITRACONAZOLE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-290 | SPORANOX | ITRACONAZOLE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-290 | SPORANOX | ITRACONAZOLE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-290 | SPORANOX | ITRACONAZOLE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 68151-2718 | itraconazole | ITRACONAZOLE | Carilion Materials Management | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80679 | SUPPL | 2024-12-23 |
| 80671 | SUPPL | 2024-12-20 |
| 80670 | SUPPL | 2024-12-20 |
| 80030 | SUPPL | 2024-10-29 |
| 80021 | SUPPL | 2024-10-28 |
| 77409 | SUPPL | 2024-02-07 |
| 77405 | SUPPL | 2024-02-06 |
| 75905 | SUPPL | 2023-10-24 |
| 75881 | SUPPL | 2023-10-20 |
| 72809 | SUPPL | 2022-12-07 |
| 72797 | SUPPL | 2022-12-06 |
| 57947 | SUPPL | 2019-03-11 |
| 57945 | SUPPL | 2019-03-11 |
| 54077 | SUPPL | 2018-05-10 |
| 54062 | SUPPL | 2018-05-10 |
| 50033 | SUPPL | 2017-10-12 |
| 49991 | SUPPL | 2017-10-10 |
| 47696 | SUPPL | 2017-03-24 |
| 47659 | SUPPL | 2017-03-23 |
| 34250 | SUPPL | 2015-04-17 |
| 21134 | SUPPL | 2015-04-17 |
| 2003 | SUPPL | 2014-06-11 |
| 12198 | SUPPL | 2014-06-10 |
| 21133 | SUPPL | 2012-04-23 |
| 21132 | SUPPL | 2012-04-23 |
| 2002 | SUPPL | 2012-04-23 |
| 34249 | SUPPL | 2012-04-20 |
| 12197 | SUPPL | 2012-04-20 |
| 12196 | SUPPL | 2012-04-20 |
| 2001 | SUPPL | 2010-08-03 |
| 12195 | SUPPL | 2010-07-31 |
| 34248 | SUPPL | 2009-03-17 |
| 34247 | SUPPL | 2009-03-17 |
| 12194 | SUPPL | 2009-03-17 |
| 21131 | SUPPL | 2009-03-10 |
| 21130 | SUPPL | 2009-03-10 |
| 2000 | SUPPL | 2009-03-10 |
| 34246 | SUPPL | 2004-07-21 |
| 12193 | SUPPL | 2004-07-21 |
| 1999 | SUPPL | 2004-07-21 |
| 1998 | SUPPL | 2004-07-21 |
| 34245 | SUPPL | 2003-12-02 |
| 21129 | SUPPL | 2003-11-25 |
| 34244 | SUPPL | 2003-04-24 |
| 21128 | SUPPL | 2002-07-17 |
| 21126 | SUPPL | 2002-07-17 |
| 12192 | SUPPL | 2002-07-17 |
| 12190 | SUPPL | 2002-07-17 |
| 21127 | SUPPL | 2002-04-11 |
| 12191 | SUPPL | 2002-04-11 |