Is Adenosine still available?

Yes. Adenosine (ANDA 077425) is listed with marketing status Prescription in the FDA Orange Book.

What is Adenosine a generic of?

Adenosine is a generic (ANDA 077425) containing Adenosine. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Adenosine's TE code AP mean?

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

What is Adenosine's FDA application number?

Adenosine is approved under ANDA 077425, held by Meitheal.

Orange Book product · Generic (ANDA)

Adenosine

Generic (ANDA)ANDA 077425TE AP Meitheal

Approved

Aug 29, 2013

Application

Generic (ANDA)

TE code

Listed patents

Adenosine (Adenosine) is a generic drug approved under an ANDA (077425) in 2013, marketed by Meitheal. 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.
Aug 29, 2013
13 yr 1 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ADENOSINE

Strength

60MG/20ML (3MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

ANDA 077425

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 077425

90MG/30ML (3MG/ML)SOLUTION

Brand + generics

Active-ingredient family

Generic (ANDA) of Adenosine

View full Adenosine 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.

Adenosine — 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 Adenosine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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