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FDA Orange Book · active-ingredient family

Technetium tc-99m pyrophosphate kit

Technetium tc-99m pyrophosphate kit is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CIS-PYRO · NDA 019039

3

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CIS-PYROSUN PHARM INDS INCNDA 019039APJun 30, 1987
PHOSPHOTECBRACCONDA 017680Approved Prior to Jan 1, 1982
TECHNESCAN PYP KITCURIUMNDA 017538APApproved 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 pyrophosphate 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.