Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1mCi/ML | 0 | GALLIUM CITRATE GA 67 | GALLIUM CITRATE GA-67 |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1977-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 1979-08-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-08-23 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 17700
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"GALLIUM CITRATE GA 67","activeIngredients":"GALLIUM CITRATE GA-67","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GALLIUM CITRATE GA 67","submission":"GALLIUM CITRATE GA-67","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)