Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022277
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/27/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022277lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022277s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022277_temodar_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022277s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.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-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.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-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.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-14 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022277s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022277Orig1s014ltr.pdf | |
| 11/22/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022277s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022277Orig1s013ltr.pdf | |
| 10/06/2017 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022277Orig1s012ltr.pdf | |
| 02/12/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022277Orig1s011ltr.pdf | |
| 02/24/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022277Orig1s010ltr.pdf | |
| 09/18/2015 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022277Orig1s009ltr.pdf | |
| 04/02/2015 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022277Orig1s008ltr.pdf | |
| 05/05/2014 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022277s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022277Orig1s007ltr.pdf | |
| 06/03/2011 | SUPPL-5 | Labeling |
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-4 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf | |
| 04/26/2010 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022277s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.pdf | |
| 09/14/2023 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.pdf | |
| 09/14/2023 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.pdf | |
| 11/20/2020 | SUPPL-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022277s014lbl.pdf | |
| 11/22/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022277s013lbl.pdf | |
| 10/06/2017 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s012lbl.pdf | |
| 02/24/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s010lbl.pdf | |
| 02/12/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf | |
| 09/18/2015 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s009lbl.pdf | |
| 04/02/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s008lbl.pdf | |
| 05/05/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022277s007lbl.pdf | |
| 06/03/2011 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf | |
| 02/04/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf | |
| 04/26/2010 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022277s001lbl.pdf | |
| 02/27/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022277lbl.pdf |