Assyro AI

Orange Book product · Brand (NDA)

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

DOPAMINE HYDROCHLORIDE

Brand (NDA)NDA 018826TE APRX HOSPIRA

At a glance

Sep 30, 1983

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 30, 1983

    43 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DOPAMINE HYDROCHLORIDE

Strength

80MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 018826

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.