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Orange Book product · Generic (ANDA)

AMMONIA N 13

AMMONIA N-13

Generic (ANDA)ANDA 207025TE APRX GEN HOSP
View AMMONIA N-13 familyOpen on FDA Orange Book

At a glance

Feb 03, 2016

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 03, 2016

    10 yr 6 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

ANDA 207025

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMMONIA N-13

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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