FDA Orange Book · active-ingredient family
Technetium tc-99m mertiatide kit
Technetium tc-99m mertiatide kit is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TECHNETIUM TC 99M MERTIATIDE KIT · NDA 216820
2
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TECHNETIUM TC 99M MERTIATIDE KITRLD | JUBILANT DRAXIMAGE | NDA 216820 | — | Jan 30, 2023 | |
| TECHNESCAN MAG3RLD | CURIUM | NDA 019882 | AP | Jun 15, 1990 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TECHNETIUM TC99M MERTIATIDE KIT | MEDI-RADIOPHARMA | ANDA 206489 | AP | Feb 06, 2020 | |
| TECHNETIUM TC99M MERTIATIDE KIT | SUN PHARM INDS INC | ANDA 208994 | AP | Jul 12, 2019 |
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 mertiatide kit — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
