Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020388
Company: PIERRE FABRE
Company: PIERRE FABRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAVELBINE | VINORELBINE TARTRATE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/24/2020 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020388s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020388Orig1s037ltr.pdf | |
| 05/07/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020388s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020388Orig1s036ltr.pdf | |
| 06/22/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020388s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020388Orig1s035ltr.pdf | |
| 10/27/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2014 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020388s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020388Orig1s027ltr.pdf | |
| 11/05/2002 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20388se8-014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020388_S014_NAVELBINE_INJECTION_AP.pdf | |
| 04/03/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/25/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/02/2001 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20388s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20388s10ltr.pdf | |
| 05/12/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/08/2000 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388s008_Navelbine.cfm | |
| 10/16/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/16/1998 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/06/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/16/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1997 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020388_S003_NAVELBINE INJECTION_AP.pdf |
| 05/24/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/24/2020 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020388s037lbl.pdf | |
| 05/07/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020388s036lbl.pdf | |
| 06/22/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020388s035lbl.pdf | |
| 03/14/2014 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020388s027lbl.pdf | |
| 11/05/2002 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf | |
| 10/02/2001 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20388s10lbl.pdf | |
| 06/08/2000 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf |