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Orange Book product · Generic (ANDA)

AMMONIA N 13

AMMONIA N-13

Generic (ANDA)ANDA 203543TE APRX SOFIE
View AMMONIA N-13 familyOpen on FDA Orange Book

At a glance

Dec 14, 2012

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 14, 2012

    13 yr 9 mo 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 203543

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.

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