Orange Book product · Brand (NDA)
CHOLETEC
TECHNETIUM TC-99M MEBROFENIN KIT
Brand (NDA)NDA 018963TE APRX BRACCO
At a glance
Jan 21, 1987
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 21, 1987
40 yr ago
Today
Pharmaceutical detail
Active ingredient
TECHNETIUM TC-99M MEBROFENIN KIT
Strength
N/A
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 018963
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.
