Assyro AI

Orange Book product · Brand (NDA)

AK-FLUOR 25%

FLUORESCEIN SODIUM

Brand (NDA)NDA 022186DISCN LONG GROVE PHARMS

At a glance

Aug 08, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 08, 2008

    18 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUORESCEIN SODIUM

Strength

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022186

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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

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