← FDA DRUG APPROVALS
FDA NDA · NDA019039
KIT FOR THE PREPARATION OF TECHNETIUM TC99M PYROPHOSPHATE
technetium tc99m pyrophosphate
Sponsor: SUN PHARM INDS INC
APPLICATION
NDA019039
TYPE
NDA
ORIGINAL APPROVAL
1987-06-30
LATEST ACTION
2025-05-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CIS-PYROPrescription
TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A · INJECTABLE · INJECTION
Approval history
2014-11-24Manufacturing (CMC) · Supplement 9 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 3 · standardAP
1997-05-27Manufacturing (CMC) · Supplement 1 · standardAP
1987-06-30Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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