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FDA Orange Book · active-ingredient family

Adenosine

Adenosine: 2 brands, 21 generics; first approved Oct 30, 1989; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 21 ANDA applications approved.

Brands (NDA)
2
Generics (ANDA)
21
Listed patents
0
Presentations
31

Brand (NDA) products

Originator applications
  • NDA 02005919952 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSDiscontinued
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSDiscontinued
  • NDA 0199371989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued

Generic (ANDA) products (21)

Abbreviated applications
  • ADENOSINE
    ANDA 2055682018
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 2067782018
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 07789720172 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
  • ADENOSINE
    ANDA 20533120172 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
  • ADENOSINE
    ANDA 09045020142 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
  • ADENOSINE
    ANDA 20231320142 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
  • ADENOSINE
    ANDA 09021220142 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
  • ADENOSINE
    ANDA 20388320142 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSDiscontinued
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSDiscontinued
  • ADENOSINE
    ANDA 0786402014
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued
  • ADENOSINERS
    ANDA 07742520132 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    60MG/20ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
    90MG/30ML (3MG/ML)SOLUTIONINTRAVENOUSRxAP
  • ADENOSINE
    ANDA 0902202009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued
  • ADENOSINE
    ANDA 0786862009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 0900102009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued
  • ADENOSINERS
    ANDA 0780762008
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 0786762008
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued
  • ADENOSINE
    ANDA 0772832007
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 0771332005
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 0764042004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 0765002004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONRxAP
  • ADENOSINE
    ANDA 0765012004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued
  • ADENOSINE
    ANDA 0765642004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MG/MLINJECTABLEINJECTIONDiscontinued

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span
First approval
37 yr 3 mo ago
Most recent approval
8 yr 5 mo ago

Approvals span 1989–2018 across 23 FDA applications.

Brand (NDA) 29%
Generic (ANDA) 2191%

Adenosine: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

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