Orange Book product · Brand (NDA)

SFROWASA

MESALAMINE

Brand (NDA)NDA 019618TE ABRX MYLAN SPECIALITY LP

Jun 20, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 20, 2008
18 yr 3 mo ago
Today
Patent 7645801 expires
Listed drug substance patent expiration.
Jul 24, 2027
in 1 yr 1 mo

Active ingredient

MESALAMINE

Strength

4GM/60ML

Dosage form

ENEMA

Route

RECTAL

TE code

Application

NDA 019618

Product number

002

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
7645801	Jul 24, 2027	in 1 yr 1 mo	SubstanceProduct