FDA Orange Book · active-ingredient family
Potassium iodide
Potassium iodide is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IOSAT · NDA 018664
3
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IOSATRLD×2 | ANBEX | NDA 018664 | — | May 12, 2011 | |
| POTASSIUM IODIDERLD | ROXANE | NDA 018551 | — | Feb 19, 1982 | |
| THYRO-BLOCK | MEDA PHARMS | NDA 018307 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM IODIDE | MISSION PHARMACAL | ANDA 206211 | — | Mar 24, 2016 | |
| THYROSHIELD | ARCO PHARMS LLC | ANDA 077218 | — | Jan 12, 2005 | |
| THYROSAFE×2 | BTG INTL | ANDA 076350 | — | Sep 10, 2002 |
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.
Potassium iodide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
