APPLICATION
NDA006799
TYPE
NDA
ORIGINAL APPROVAL
1950-09-29
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
RUBRAMIN PC · ReferenceDiscontinued
CYANOCOBALAMIN 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
RUBRAMIN PC · ReferenceDiscontinued
CYANOCOBALAMIN 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
RUBRAMIN PCDiscontinued
CYANOCOBALAMIN 0.1MG/ML · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 14AP
2007-12-07Labeling · Supplement 4AP
1995-11-28Labeling · Supplement 15 · standardAP
1987-10-14Manufacturing (CMC) · Supplement 13 · standardAP
1986-05-05Manufacturing (CMC) · Supplement 12 · standardAP
1985-07-31Manufacturing (CMC) · Supplement 9 · standardAP
1984-10-01Labeling · Supplement 11AP
1984-07-09Labeling · Supplement 10AP
1983-12-15Labeling · Supplement 8AP
1980-08-26Labeling · Supplement 7AP
1979-01-19Labeling · Supplement 6AP
1950-09-29Type 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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