Assyro AI

Orange Book product · Brand (NDA)

IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

Brand (NDA)NDA 019514DISCN HOSPIRA

At a glance

May 08, 1986

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 08, 1986

    40 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

Strength

5GM/100ML;111MG/100ML;256MG/100ML;146MG/100ML;207MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019514

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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.