Orange Book product · Brand (NDA)

MYTESI

CROFELEMER

Brand (NDA)NDA 202292RX NAPO PHARMS INC

Dec 31, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 31, 2012
13 yr 8 mo ago
Today
Patent 8962680 expires
Listed method-of-use patent (U-1319) expiration.
Oct 31, 2031
in 5 yr 5 mo
Patent 9585868 expires
Listed method-of-use patent (U-1319) expiration.
Oct 31, 2031
in 5 yr 5 mo

Active ingredient

CROFELEMER

Strength

125MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 202292

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8962680	Oct 31, 2031	in 5 yr 5 mo	U-1319
9585868	Oct 31, 2031	in 5 yr 5 mo	U-1319