Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021029
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMODAR | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
TEMODAR | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
TEMODAR | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
TEMODAR | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
TEMODAR | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
TEMODAR | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/14/2023 | SUPPL-38 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf | |
09/14/2023 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf | |
09/14/2023 | SUPPL-36 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf | |
11/20/2020 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21029s035lbl.pdf | |
11/22/2019 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021029s033lbl.pdf | |
10/06/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s032lbl.pdf | |
02/24/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s030lbl.pdf | |
02/12/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf | |
09/18/2015 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf | |
04/02/2015 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf | |
04/02/2015 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf | |
05/05/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf | |
01/08/2013 | SUPPL-22 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf |
06/03/2011 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf | |
02/04/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf | |
04/26/2010 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf | |
10/19/2006 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf | |
10/19/2006 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf | |
03/15/2005 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf | |
03/11/2003 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf | |
01/18/2002 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf | |
08/11/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf |