Assyro AI

FDA Orange Book · active-ingredient family

Technetium tc-99m etidronate kit

Technetium tc-99m etidronate kit is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

4

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CINTICHEM TECHNETIUM 99M HEDSPAGE HEALTHCARENDA 017653Approved Prior to Jan 1, 1982
MPI STANNOUS DIPHOSPHONATEGE HEALTHCARENDA 017667Approved Prior to Jan 1, 1982
OSTEOSCANMALLINCKRODTNDA 017454Approved Prior to Jan 1, 1982
TECHNETIUM TC 99M DIPHOSPHONATE-TIN KITGE HEALTHCARENDA 017562Approved 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 etidronate kit — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.