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Orange Book product · Brand (NDA)

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FLUORESCEIN SODIUM

Brand (NDA)NDA 022186TE APRX LONG GROVE PHARMS
View FLUORESCEIN SODIUM familyOpen on FDA Orange Book

At a glance

Aug 08, 2008

Approved

Brand (NDA)

Application

AP

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/5ML (EQ 100MG BASE/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

NDA 022186

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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