FDA Orange Book · active-ingredient family
Liothyronine sodium
Liothyronine sodium is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRIOSTAT · NDA 020105
2
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIOSTATRLD | PH HEALTH | NDA 020105 | — | Dec 31, 1991 | |
| CYTOMELRLD×3 | KING PHARMS | NDA 010379 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIOTHYRONINE SODIUM×3 | BIOCON PHARMA | ANDA 218070 | AB | Feb 06, 2024 | |
| LIOTHYRONINE SODIUM×3 | ZYDUS LIFESCIENCES | ANDA 214803 | AB | Jan 22, 2021 | |
| LIOTHYRONINE SODIUM×3 | TEVA PHARMS USA | ANDA 211510 | AB | Oct 26, 2018 | |
| LIOTHYRONINE SODIUM×3 | SUN PHARM | ANDA 091382 | AB | Apr 20, 2016 | |
| LIOTHYRONINE SODIUM×3 | SIGMAPHARM LABS LLC | ANDA 200295 | AB | Nov 29, 2012 | |
| LIOTHYRONINE SODIUM×3 | PHARMOBEDIENT | ANDA 090326 | — | Jul 14, 2009 | |
| LIOTHYRONINE SODIUM×3 | DR REDDYS LABS SA | ANDA 090097 | AB | Mar 20, 2009 | |
| LIOTHYRONINE SODIUM | XGEN PHARMS | ANDA 076923 | — | Aug 17, 2005 | |
| LIOTHYRONINE SODIUM | WATSON LABS | ANDA 085753 | — | Feb 03, 1982 | |
| LIOTHYRONINE SODIUM | WATSON LABS | ANDA 085755 | — | Jan 25, 1982 |
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.
Liothyronine sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
