FDA Orange Book · active-ingredient family
Technetium tc-99m mebrofenin kit
Technetium tc-99m mebrofenin kit is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CHOLETEC · NDA 018963
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHOLETECRLD | BRACCO | NDA 018963 | AP | Jan 21, 1987 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TECHNETIUM TC-99M MEBROFENIN | SUN PHARM INDS INC | ANDA 078242 | AP | Jan 29, 2008 |
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 mebrofenin kit — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
