Choline c-11
Choline c-11: 1 brand, 4 generics; first approved Sep 12, 2012; generic available.
Generic available: 4 ANDA applications approved.
Brand (NDA) products
- CHOLINE C-11RLDRSMCPRFNDA 2031552012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4-33.1mCi/ML INJECTABLE INTRAVENOUS Rx AP
Generic (ANDA) products (4)
- CHOLINE C-11UCSF RODIOPHARMANDA 2084442017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4-33.1mCi/ML INJECTABLE INTRAVENOUS Discontinued - - CHOLINE C-11WA UNIV SCH MEDANDA 2084132017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4-33.1mCi/ML INJECTABLE INTRAVENOUS Discontinued - - CHOLINE C-11DECATURANDA 2063192015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4-33.1mCi/ML INJECTABLE INTRAVENOUS Rx AP - CHOLINE C-11UNIV TX MD ANDERSONANDA 2056902015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4-100mCi/ML INJECTABLE INTRAVENOUS Discontinued -
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.
Approval history
Approvals span 2012–2017 across 5 FDA applications.
Choline c-11: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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