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Orange Book product · Brand (NDA)

AMMONIA N 13

AMMONIA N-13

Brand (NDA)NDA 022119TE APRX FEINSTEIN
View AMMONIA N-13 familyOpen on FDA Orange Book

At a glance

Aug 23, 2007

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 23, 2007

    19 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMMONIA N-13

Strength

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

NDA 022119

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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