Orange Book product · Generic (ANDA)
SODIUM IODIDE I 131
SODIUM IODIDE I-131
At a glance
Jun 12, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2025
1 yr ago
Today
Pharmaceutical detail
Active ingredient
SODIUM IODIDE I-131
Strength
250-1000mCi
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 213615
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SODIUM IODIDE I-131
- 2005SODIUM IODIDE I 131Brand (NDA)
NDA 021305 · JUBILANT
- —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
- 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.
