Assyro AI

Orange Book product · Brand (NDA)

POKONZA

POTASSIUM CHLORIDE

Brand (NDA)NDA 208019RX GENUS

At a glance

Aug 25, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 25, 2023

    2 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

POTASSIUM CHLORIDE

Strength

10MEQ

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 208019

Product number

002

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.