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Orange Book product · Generic (ANDA)

AMMONIA N 13

AMMONIA N-13

Generic (ANDA)ANDA 204514TE APRX JOHNS HOPKINS UNIV

At a glance

Aug 19, 2014

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 19, 2014

    12 yr 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 204514

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.