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| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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| GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| 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 |