Is Ammonia N 13 still available?

Yes. Ammonia N 13 (ANDA 203543) is listed with marketing status Prescription in the FDA Orange Book.

What is Ammonia N 13 a generic of?

Ammonia N 13 is a generic (ANDA 203543) containing Ammonia N-13. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Ammonia N 13's TE code AP mean?

AP is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Ammonia N 13 substitutable for its reference brand with no expected difference in clinical effect.

What is Ammonia N 13's FDA application number?

Ammonia N 13 is approved under ANDA 203543, held by Sofie.

Orange Book product · Generic (ANDA)

Ammonia N 13

Ammonia N-13

Generic (ANDA)ANDA 203543TE AP Sofie

Approved

Dec 14, 2012

Application

Generic (ANDA)

TE code

Listed patents

Ammonia N 13 (Ammonia N-13) is a generic drug approved under an ANDA (203543) in 2012, marketed by Sofie. Its therapeutic-equivalence code is AP, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 14, 2012
13 yr 9 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AMMONIA N-13

Strength

3.75mCi-260mCi/ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

ANDA 203543

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

Generic (ANDA) of Ammonia N-13

View full Ammonia N-13 family

Orange Book patent file

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.

Ammonia N 13 — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Ammonia N-13 active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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