Orange Book product · Brand (NDA)

FARYDAK

PANOBINOSTAT LACTATE

Brand (NDA)NDA 205353DISCN SECURA

Feb 23, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 23, 2015
11 yr 6 mo ago
Today
Patent 7989494 expires
Listed drug substance patent expiration.
Jan 17, 2028
in 1 yr 7 mo
Patent 8883842 expires
Listed method-of-use patent (U-1669) expiration.
Jun 13, 2028
in 2 yr

Active ingredient

PANOBINOSTAT LACTATE

Strength

EQ 10MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 205353

Product number

001

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
7989494	Jan 17, 2028	in 1 yr 7 mo	SubstanceProduct
8883842	Jun 13, 2028	in 2 yr	U-1669