Is there a generic for Choline c-11?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Choline c-11, referencing the brand CHOLINE C-11. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Choline c-11?

CHOLINE C-11 (NDA 203155, MCPRF) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Choline c-11 are approved?

Choline c-11 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Choline c-11

Choline c-11: 1 brand, 4 generics; first approved Sep 12, 2012; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 4 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CHOLINE C-11RLDRS

MCPRFNDA 2031552012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4-33.1mCi/ML	INJECTABLE	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (4)

CHOLINE C-11

UCSF RODIOPHARMANDA 2084442017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4-33.1mCi/ML	INJECTABLE	INTRAVENOUS	Discontinued	—

CHOLINE C-11

WA 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-11

DECATURANDA 2063192015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4-33.1mCi/ML	INJECTABLE	INTRAVENOUS	Rx	AP

CHOLINE C-11

UNIV TX MD ANDERSONANDA 2056902015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4-100mCi/ML	INJECTABLE	INTRAVENOUS	Discontinued	—

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.

FDA approval span

Approval history

First approval

Sep 12, 2012

14 yr ago

Most recent approval

Nov 20, 2017

8 yr 9 mo ago

Approvals span 2012–2017 across 5 FDA applications.

Brand (NDA) 120%

Generic (ANDA) 480%

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.

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