Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022277
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
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
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

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