Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 40MG BASE/VIAL | 0 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-02-09 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
BE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 216171
[companyName] => BE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"40MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-02-09
)
)