Orange Book product · Brand (NDA)

MOXEZA

MOXIFLOXACIN HYDROCHLORIDE

Brand (NDA)NDA 022428DISCN HARROW EYE

Nov 19, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 19, 2010
15 yr 10 mo ago
Today
Patent 8450311 expires
Listed drug product patent expiration.
May 29, 2029
in 3 yr
Patent 9114168 expires
Listed drug product patent expiration.
May 29, 2029
in 3 yr

Active ingredient

MOXIFLOXACIN HYDROCHLORIDE

Strength

EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 022428

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
8450311	May 29, 2029	in 3 yr	Product
9114168	May 29, 2029	in 3 yr	Product