Assyro AI

Orange Book product · Brand (NDA)

ASCLERA

POLIDOCANOL

Brand (NDA)NDA 021201RX CHEMISCH FBRK KRSSLR

At a glance

Mar 30, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 30, 2010

    16 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

POLIDOCANOL

Strength

10MG/2ML (5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 021201

Product number

001

Marketing status

RX

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.