Assyro AI

Orange Book product · Brand (NDA)

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GADOVERSETAMIDE

Brand (NDA)NDA 020976DISCN LIEBEL-FLARSHEIM
View GADOVERSETAMIDE familyOpen on FDA Orange Book

At a glance

Dec 08, 1999

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 08, 1999

    26 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GADOVERSETAMIDE

Strength

4963.5MG/15ML (330.9MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 020976

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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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