Orange Book product · Brand (NDA)

ARYMO ER

MORPHINE SULFATE

Brand (NDA)NDA 208603DISCN ZYLA

Jan 09, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 09, 2017
9 yr 7 mo ago
Today
Patent 9044402 expires
Listed drug product patent expiration.
Jul 01, 2033
in 7 yr 2 mo
Patent 9549899 expires
Listed drug product patent expiration.
Jul 01, 2033
in 7 yr 2 mo

Active ingredient

MORPHINE SULFATE

Strength

15MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208603

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
9044402	Jul 01, 2033	in 7 yr 2 mo	ProductU-1556
9549899	Jul 01, 2033	in 7 yr 2 mo	ProductU-1556