Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020509
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMZAR | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| GEMZAR | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/15/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020509Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2019 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020509s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020509Orig1s082ltr.pdf | |
| 11/20/2018 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020509Orig1s081ltr.pdf | |
| 06/08/2018 | SUPPL-80 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf | |
| 09/13/2017 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020509s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020509Orig1s079ltr.pdf | |
| 05/08/2014 | SUPPL-77 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s077ltr.pdf | |
| 08/11/2014 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2014 | SUPPL-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s075ltr.pdf | |
| 05/07/2013 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020509s072lbl.pdf | |
| 02/04/2011 | SUPPL-69 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf | |
| 03/19/2010 | SUPPL-64 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020509s064ltr.pdf | |
| 07/14/2006 | SUPPL-39 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s039_ltr.pdf |
| 04/05/2006 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s037ltr.pdf |
| 04/26/2005 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020509_S033_GEMZAR.pdf | |
| 04/20/2005 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s032ltr.pdf | |
| 05/19/2004 | SUPPL-29 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20509se1-029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020509_S029_GEMZAR_AP.pdf | |
| 11/13/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20509s021ltr.pdf |
| 05/18/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/22/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/2003 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20509slr013ltr.pdf | |
| 11/23/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1998 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20509lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20509ltr.pdf | |
| 09/18/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2019 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020509s082lbl.pdf | |
| 11/20/2018 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s081lbl.pdf | |
| 06/08/2018 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf | |
| 06/08/2018 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf | |
| 09/13/2017 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020509s079lbl.pdf | |
| 06/10/2014 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf | |
| 05/08/2014 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s077lbl.pdf | |
| 05/07/2013 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020509s072lbl.pdf | |
| 02/04/2011 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf | |
| 02/04/2011 | SUPPL-69 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf | |
| 03/19/2010 | SUPPL-64 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf | |
| 04/26/2005 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf | |
| 04/20/2005 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s032lbl.pdf | |
| 05/19/2004 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf | |
| 01/06/2003 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf | |
| 08/25/1998 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20509lbl.pdf |