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Orange Book product · Brand (NDA)

DOTAREM

GADOTERATE MEGLUMINE

Brand (NDA)NDA 204781TE APRX GUERBET
View GADOTERATE MEGLUMINE familyOpen on FDA Orange Book

At a glance

Mar 31, 2017

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 31, 2017

    9 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GADOTERATE MEGLUMINE

Strength

1.8845GM/5ML (376.9MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

NDA 204781

Product number

005

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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