Orange Book product · Brand (NDA)

JUVISYNC

SIMVASTATIN; SITAGLIPTIN PHOSPHATE

Brand (NDA)NDA 202343DISCN MERCK SHARP DOHME

Sep 18, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 18, 2012
13 yr 11 mo ago
Patent 7326708 expires
Listed drug substance patent expiration.
Apr 11, 2026
2 mo ago
Today
Patent 7326708*PED expires
Listed listed patent expiration.
Oct 11, 2026
in 4 mo

Active ingredient

SIMVASTATIN; SITAGLIPTIN PHOSPHATE

Strength

10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 202343

Product number

004

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7326708	Apr 11, 2026	2 mo ago	SubstanceProductU-1188
7326708*PED	Oct 11, 2026	in 4 mo