Application 020388
- Type
- NDA
- Sponsor
- PIERRE FABRE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAVELBINE | VINORELBINE TARTRATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64370-532 | NAVELBINE | Vinorelbine Tartrate | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-532 | NAVELBINE | Vinorelbine Tartrate | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-532 | NAVELBINE | Vinorelbine Tartrate | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61686 | SUPPL | 2020-01-27 |
| 61647 | SUPPL | 2020-01-27 |
| 58639 | SUPPL | 2019-05-13 |
| 58615 | SUPPL | 2019-05-08 |
| 54713 | SUPPL | 2018-06-28 |
| 54711 | SUPPL | 2018-06-27 |
| 34598 | SUPPL | 2014-03-19 |
| 2466 | SUPPL | 2014-03-19 |
| 20631 | SUPPL | 2007-07-06 |
| 20629 | SUPPL | 2007-04-11 |
| 2464 | SUPPL | 2003-07-24 |
| 34597 | SUPPL | 2003-04-22 |
| 12530 | SUPPL | 2002-11-05 |
| 2465 | SUPPL | 2002-11-05 |
| 20630 | SUPPL | 2000-06-08 |
| 12529 | SUPPL | 2000-06-08 |
| 2463 | SUPPL | 2000-06-08 |