FDA Orange Book · active-ingredient family
Technetium tc-99m sulfur colloid kit
Technetium tc-99m sulfur colloid kit is approved as 4 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AN-SULFUR COLLOID · NDA 017858
4
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AN-SULFUR COLLOIDRLD | SUN PHARM INDS INC | NDA 017858 | AP | Approved Prior to Jan 1, 1982 | |
| TECHNECOLL | MALLINCKRODT | NDA 017059 | — | Approved Prior to Jan 1, 1982 | |
| TECHNETIUM TC 99M TSC | GE HEALTHCARE | NDA 017784 | — | Approved Prior to Jan 1, 1982 | |
| TESULOID | BRACCO | NDA 016923 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TECHNETIUM TC-99M SULFUR COLLOID KIT | JUBILANT | ANDA 213516 | AP | Nov 09, 2023 |
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.
Technetium tc-99m sulfur colloid kit — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
