Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;INTRAVENOUS | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | 0 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-11-02 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
PRAXGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 213797
[companyName] => PRAXGEN
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 175MG BASE\/17.5ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-11-02
)
)