Orange Book product · Brand (NDA)
CARDIOLITE
TECHNETIUM TC-99M SESTAMIBI KIT
Brand (NDA)NDA 019785TE APRX SHINE
At a glance
Dec 21, 1990
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 1990
36 yr ago
Today
Pharmaceutical detail
Active ingredient
TECHNETIUM TC-99M SESTAMIBI KIT
Strength
N/A
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 019785
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.

