Orange Book product · Brand (NDA)
SODIUM IODIDE I 131
SODIUM IODIDE I-131
At a glance
May 19, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 2005
21 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM IODIDE I-131
Strength
0.009-0.1mCi
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021305
Product number
006
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —IODOTOPEBrand (NDA)
NDA 010929 · BRACCO
- —SODIUM IODIDE I 131Brand (NDA)
NDA 017316 · CIS
- —SODIUM IODIDE I 131Brand (NDA)
NDA 016515 · CURIUM
- —SODIUM IODIDE I 131Brand (NDA)
NDA 016517 · CURIUM
- —SODIUM IODIDE I 131Brand (NDA)
NDA 017315 · SUN PHARM INDS INC
- 2025SODIUM IODIDE I 131Generic (ANDA)
ANDA 213615 · CARDINAL HLTH 414
- 2020SODIUM IODIDE I 131Generic (ANDA)
ANDA 209166 · INTL ISOTOPES
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.
