Orange Book product · Brand (NDA)

APRISO

MESALAMINE

Brand (NDA)NDA 022301TE ABRX SALIX

Oct 31, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 31, 2008
17 yr 11 mo ago
Today
Patent 8865688 expires
Listed method-of-use patent (U-1310) expiration.
May 01, 2030
in 3 yr 11 mo

Active ingredient

MESALAMINE

Strength

375MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 022301

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
8865688	May 01, 2030	in 3 yr 11 mo	U-1310