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Orange Book product · Brand (NDA)

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

RIBOFLAVIN 5'-PHOSPHATE SODIUM

Brand (NDA)NDA 203324RX GLAUKOS
View RIBOFLAVIN 5'-PHOSPHATE SODIUM familyOpen on FDA Orange Book

At a glance

Apr 15, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 15, 2016

    10 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

RIBOFLAVIN 5'-PHOSPHATE SODIUM

Strength

EQ 0.146% BASE/ML;EQ 0.146% BASE/ML

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 203324

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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