Assyro AI

Orange Book product · Brand (NDA)

PROHANCE

GADOTERIDOL

Brand (NDA)NDA 020131TE APRX BRACCO
View GADOTERIDOL familyOpen on FDA Orange Book

At a glance

Nov 16, 1992

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 16, 1992

    34 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GADOTERIDOL

Strength

279.3MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 020131

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

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