Orange Book product · Brand (NDA)

FLUORESCITE

FLUORESCEIN SODIUM

Brand (NDA)NDA 021980TE APRX ALCON LABS INC

View FLUORESCEIN SODIUM family Open on FDA Orange Book

At a glance

Mar 28, 2006

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 28, 2006
20 yr 6 mo ago
Today

Pharmaceutical detail

Active ingredient

FLUORESCEIN SODIUM

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 021980

Product number

001

Marketing status

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.

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

Book a Demo