Assyro AI

Orange Book product · Brand (NDA)

DEXTROSE 60% IN PLASTIC CONTAINER

DEXTROSE

Brand (NDA)NDA 017521DISCN BAXTER HLTHCARE

At a glance

Mar 26, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 26, 1982

    44 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXTROSE

Strength

60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 017521

Product number

005

Marketing status

DISCN

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.