Assyro AI

Orange Book product · Brand (NDA)

AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Brand (NDA)NDA 019712DISCN ABBOTT

At a glance

Sep 08, 1988

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 08, 1988

    38 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Strength

4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019712

Product number

002

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.