FDA Orange Book · active-ingredient family
Choline c-11
Choline c-11 is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CHOLINE C-11 · NDA 203155
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHOLINE C-11RLD | MCPRF | NDA 203155 | AP | Sep 12, 2012 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHOLINE C-11 | UCSF RODIOPHARM | ANDA 208444 | — | Nov 20, 2017 | |
| CHOLINE C-11 | WA UNIV SCH MED | ANDA 208413 | — | Jan 10, 2017 | |
| CHOLINE C-11 | DECATUR | ANDA 206319 | AP | Nov 13, 2015 | |
| CHOLINE C-11 | UNIV TX MD ANDERSON | ANDA 205690 | — | Oct 29, 2015 |
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.
Choline c-11 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
