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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/11/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21029_Temodar.cfm |
Supplements
| 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)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021029Orig1s036,s037,s038;022277Orig1s017,s018,s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021029Orig1s036,037,038,022277Orig1s017,018,019TOC.cfm | |
| 09/14/2023 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021029Orig1s036,s037,s038;022277Orig1s017,s018,s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021029Orig1s036,037,038,022277Orig1s017,018,019TOC.cfm | |
| 09/14/2023 | SUPPL-36 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021029Orig1s036,s037,s038;022277Orig1s017,s018,s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021029Orig1s036,037,038,022277Orig1s017,018,019TOC.cfm | |
| 11/20/2020 | SUPPL-35 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21029s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021029Orig1s035ltr.pdf | |
| 11/22/2019 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021029s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021029Orig1s033ltr.pdf | |
| 10/06/2017 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021029Orig1s032ltr.pdf | |
| 02/12/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021029Orig1s031ltr.pdf | |
| 02/24/2017 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021029Orig1s030ltr.pdf | |
| 09/18/2015 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s029ltr.pdf | |
| 04/02/2015 | SUPPL-28 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s028ltr.pdf | |
| 09/19/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021029Orig1s026ltr.pdf | |
| 10/10/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2013 | SUPPL-22 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf | |
| 06/03/2011 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022277s005,021029s021ltr.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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf | |
| 10/19/2006 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s012ltr.pdf | |
| 03/31/2006 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s008, s011ltr.pdf |
| 04/22/2005 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021029s010ltr.pdf |
| 03/30/2005 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s009ltr.pdf |
| 03/15/2005 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s008ltr.pdf | |
| 06/29/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029slr007ltr.pdf |
| 07/15/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029s006ltr.pdf |
| 03/11/2003 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21029se8-005ltr.pdf | |
| 01/18/2002 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21029s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21029-S004_TEMODAR_review.pdf | |
| 03/05/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf | |
| 10/19/2006 | SUPPL-12 | Labeling-Container/Carton Labels | 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 |