Orange Book product · Brand (NDA)

FLOLIPID

SIMVASTATIN

Brand (NDA)NDA 206679RX SALERNO PHARMS

Apr 21, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 21, 2016
10 yr 4 mo ago
Today
Patent 10300041 expires
Listed drug product patent expiration.
Apr 26, 2027
in 10 mo
Patent 9597289 expires
Listed drug product patent expiration.
Feb 23, 2030
in 3 yr 9 mo

Active ingredient

SIMVASTATIN

Strength

20MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 206679

Product number

001

Marketing status

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
10300041	Apr 26, 2027	in 10 mo	Product
9597289	Feb 23, 2030	in 3 yr 9 mo	Product