Orange Book product · Brand (NDA)

PIZENSY

LACTITOL

Brand (NDA)NDA 211281DISCN BRAINTREE LABS

Feb 12, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 12, 2020
6 yr 5 mo ago
Today
Patent 10806743 expires
Listed method-of-use patent (U-1516) expiration.
May 12, 2037
in 11 yr 1 mo

Active ingredient

LACTITOL

Strength

10GM

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 211281

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
10806743	May 12, 2037	in 11 yr 1 mo	U-1516