Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 0.9MEQ/ML | 0 | SODIUM BICARBONATE | SODIUM BICARBONATE |
002 | INJECTABLE;INJECTION | 1MEQ/ML | 0 | SODIUM BICARBONATE | SODIUM BICARBONATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2021-06-14 | UNKNOWN |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202494
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"0.9MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"1MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-03-06
)
)