Application 020671
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYCAMTIN | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0674 | HYCAMTIN | topotecan hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0674 | HYCAMTIN | topotecan hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0674 | HYCAMTIN | topotecan hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0674 | HYCAMTIN | topotecan hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0674 | HYCAMTIN | topotecan hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0674 | HYCAMTIN | topotecan hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60566 | SUPPL | 2019-10-15 |
| 60481 | SUPPL | 2019-10-09 |
| 57685 | ORIG | 2019-02-15 |
| 55454 | SUPPL | 2018-09-12 |
| 55390 | SUPPL | 2018-09-06 |
| 35122 | SUPPL | 2015-06-04 |
| 25488 | SUPPL | 2015-06-04 |
| 3057 | SUPPL | 2014-03-05 |
| 13183 | SUPPL | 2014-03-04 |
| 35121 | SUPPL | 2010-04-05 |
| 25487 | SUPPL | 2010-04-05 |
| 13182 | SUPPL | 2010-04-05 |
| 3056 | SUPPL | 2010-04-05 |
| 3055 | SUPPL | 2006-06-20 |
| 13181 | SUPPL | 2006-06-15 |
| 3054 | SUPPL | 2003-06-08 |
| 35120 | SUPPL | 2003-05-29 |
| 25486 | SUPPL | 2003-03-28 |
| 23974 | SUPPL | 2003-03-26 |
| 3053 | SUPPL | 2002-03-06 |
| 25485 | SUPPL | 1998-11-30 |
| 20813 | SUPPL | 1998-11-30 |
| 13180 | SUPPL | 1998-11-30 |