Assyro AI

Orange Book product · Brand (NDA)

OCUFLOX

OFLOXACIN

Brand (NDA)NDA 019921TE ATRX ALLERGAN
View OFLOXACIN familyOpen on FDA Orange Book

At a glance

Jul 30, 1993

Approved

Brand (NDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 30, 1993

    33 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OFLOXACIN

Strength

0.3%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

NDA 019921

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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

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