APPLICATION
NDA013993
TYPE
NDA
ORIGINAL APPROVAL
1971-12-27
LATEST ACTION
2001-03-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CHROMITOPE SODIUMDiscontinued
SODIUM CHROMATE CR-51 200uCi/ML · INJECTABLE · INJECTION
CHROMITOPE SODIUMDiscontinued
SODIUM CHROMATE CR-51 2mCi/VIAL · INJECTABLE · INJECTION
Approval history
2001-03-06Manufacturing (CMC) · Supplement 20 · standardAP
2000-02-25Manufacturing (CMC) · Supplement 19 · standardAP
1997-10-10Labeling · Supplement 18 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 17 · standardAP
1984-03-08Labeling · Supplement 16AP
1984-01-30Labeling · Supplement 15AP
1980-05-16Labeling · Supplement 12AP
1978-05-30Labeling · Supplement 11AP
1977-08-29Labeling · Supplement 8AP
1977-08-29Manufacturing (CMC) · Supplement 10 · standardAP
1977-08-29Labeling · Supplement 9AP
1977-08-27Labeling · Supplement 7AP
1977-01-18Labeling · Supplement 6AP
1976-04-21Manufacturing (CMC) · Supplement 5 · standardAP
1971-12-27Type 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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