Juvisync

NDA 202343, held by Merck Sharp Dohme. Simvastatin; Sitagliptin Phosphate.

As of Nov 14, 2026, NDA 202343 (Juvisync), held by Merck Sharp Dohme, was first approved by FDA on Oct 7, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 7, 2011
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Sep 18, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 7, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

6 strengths and forms


Juvisync10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Simvastatin; Sitagliptin Phosphate	DiscontinuedReference drug
Juvisync20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Simvastatin; Sitagliptin Phosphate	DiscontinuedReference drug
Juvisync40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Simvastatin; Sitagliptin Phosphate	DiscontinuedReference drug
Juvisync10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Simvastatin; Sitagliptin Phosphate	DiscontinuedReference drug
Juvisync20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Simvastatin; Sitagliptin Phosphate	DiscontinuedReference drug
Juvisync40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Simvastatin; Sitagliptin Phosphate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Feb 24, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Nov 8, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 25, 2013	Supplement 8Labeling · Standard review	Approved	Label Letter
Aug 19, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Feb 11, 2013	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 31, 2012	Supplement 5Labeling · Standard review	Approved	Letter Label
Oct 31, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Sep 18, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 18, 2012	Supplement 2Labeling · Standard review	Approved	Letter Label
Sep 18, 2012	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202343
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters