FDA Orange Book · active-ingredient family
Technetium tc-99m medronate kit
Technetium tc-99m medronate kit is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AMERSCAN MDP KIT · NDA 018335
5
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMERSCAN MDP KIT | GE HEALTHCARE | NDA 018335 | — | Aug 05, 1982 | |
| CIS-MDP | SUN PHARM INDS INC | NDA 018124 | AP | Approved Prior to Jan 1, 1982 | |
| OSTEOLITE | SUN PHARM INDS INC | NDA 017972 | — | Approved Prior to Jan 1, 1982 | |
| TECHNETIUM TC 99M MPI MDP×2 | GE HEALTHCARE | NDA 018141 | — | Approved Prior to Jan 1, 1982 | |
| TECHNETIUM TC-99M MEDRONATE KIT | CARDINAL HEALTH 414 | NDA 018107 | AP | Approved Prior to Jan 1, 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.
Technetium tc-99m medronate kit — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
