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Orange Book product · Generic (ANDA)

MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE

Generic (ANDA)ANDA 090080TE AT1RX APOTEX

At a glance

Jun 30, 2017

Approved

Generic (ANDA)

Application

AT1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 30, 2017

    9 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MOXIFLOXACIN HYDROCHLORIDE

Strength

EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT1

Application

ANDA 090080

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MOXIFLOXACIN HYDROCHLORIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.