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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202343
Company: MERCK SHARP DOHME

Medication Guide

Summary Review

Products on NDA 202343

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202343

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2011	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202343s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202343s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2014	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202343s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202343Orig1s011ltr.pdf
08/19/2013	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s010ltr.pdf
11/08/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/25/2013	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s008ltr.pdf
10/31/2012	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf
02/11/2013	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s006ltr.pdf
10/31/2012	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf
09/18/2012	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf
09/18/2012	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf
09/18/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf

Labels for NDA 202343

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2014	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202343s011lbl.pdf
10/25/2013	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s008lbl.pdf
08/19/2013	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s010lbl.pdf
02/11/2013	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s006lbl.pdf
10/31/2012	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf
10/31/2012	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf
09/18/2012	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf
09/18/2012	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf
09/18/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf
10/07/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202343s000lbl.pdf

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