Assyro AI

Orange Book product · Brand (NDA)

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

SODIUM CHLORIDE

Brand (NDA)NDA 019022TE APRX BAXTER HLTHCARE

At a glance

Nov 01, 1983

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 01, 1983

    43 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM CHLORIDE

Strength

5GM/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 019022

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.