Orange Book product · Brand (NDA)

SYNRIBO

OMACETAXINE MEPESUCCINATE

Brand (NDA)NDA 203585DISCN TEVA PHARMS INTL

Oct 26, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 26, 2012
13 yr 10 mo ago
Today
Patent 6987103 expires
Listed method-of-use patent (U-1300) expiration.
Oct 26, 2026
in 4 mo

Active ingredient

OMACETAXINE MEPESUCCINATE

Strength

3.5MG/VIAL

Dosage form

POWDER

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 203585

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
6987103	Oct 26, 2026	in 4 mo	U-1300