Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022277
Company: MERCK SHARP DOHME

• Summary Review

Products on NDA 22277

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEMODAR	TEMOZOLOMIDE	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Labels for NDA 022277

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