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FDA Orange Book · active-ingredient family

Technetium tc-99m apcitide

Technetium tc-99m apcitide: 1 brand, 0 generics; first approved Sep 14, 1998.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity: brand product(s) only.

Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1

Brand (NDA) products

Originator applications
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  • NDA 0208871998
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    N/AINJECTABLEINJECTIONDiscontinued-

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
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First approval
28 yr 6 mo ago
Most recent approval
28 yr 6 mo ago

All 1 application were approved in 1998.

Brand (NDA) 1100%
Generic (ANDA) 00%

Technetium tc-99m apcitide: 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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