Orange Book product · Brand (NDA)
CHOLINE C-11
CHOLINE C-11
Brand (NDA)NDA 203155TE APRX MCPRF
At a glance
Sep 12, 2012
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 2012
14 yr ago
Today
Pharmaceutical detail
Active ingredient
CHOLINE C-11
Strength
4-33.1mCi/ML
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 203155
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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.
