Orange Book product · Brand (NDA)

ONMEL

ITRACONAZOLE

Brand (NDA)NDA 022484DISCN SEBELA IRELAND LTD

Apr 29, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 29, 2010
16 yr 5 mo ago
Today
Patent 8486456 expires
Listed drug product patent expiration.
Oct 03, 2028
in 2 yr 4 mo

Active ingredient

ITRACONAZOLE

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022484

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
8486456	Oct 03, 2028	in 2 yr 4 mo	ProductU-1054