Assyro AI

Orange Book product · Brand (NDA)

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

POTASSIUM CHLORIDE

Brand (NDA)NDA 020161TE APRX OTSUKA ICU MEDCL

At a glance

Aug 11, 1998

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 11, 1998

    28 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

POTASSIUM CHLORIDE

Strength

2.98GM/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 020161

Product number

004

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

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