Assyro AI

Orange Book product · Brand (NDA)

DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE

Brand (NDA)NDA 019466TE APRX HOSPIRA

At a glance

Jul 15, 1985

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 15, 1985

    41 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXTROSE

Strength

5GM/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 019466

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

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