Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 0.5MEQ/ML | 0 | SODIUM BICARBONATE | SODIUM BICARBONATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-03-07 | |
LABELING; Labeling | SUPPL | 2 | AP | 2017-08-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2021-06-14 | UNKNOWN |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 10 | Null | 7 |
TE Codes
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202679
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"0.5MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/29\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-08-29
)
)