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Orange Book product · Generic (ANDA)

AMMONIA N 13

AMMONIA N-13

Generic (ANDA)ANDA 215083TE APRX METHODIST
View AMMONIA N-13 familyOpen on FDA Orange Book

At a glance

Jul 09, 2021

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 09, 2021

    5 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

AMMONIA N-13

Strength

3.75mCi-260mCi/ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 215083

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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