Application Sponsors
Marketing Status
Application Products
001 | N/A;N/A | N/A;N/A;N/A | 0 | DICOPAC KIT | CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58 |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1974-06-10 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1978-05-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-01-16 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 1994-08-05 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 17406
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"DICOPAC KIT","activeIngredients":"CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58","strength":"N\/A;N\/A;N\/A","dosageForm":"N\/A;N\/A","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DICOPAC KIT","submission":"CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58","actionType":"N\/A;N\/A;N\/A","submissionClassification":"N\/A;N\/A","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)