Application Sponsors
ANDA 203619 | CUSTOPHARM INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 50MG/ML | 0 | PENTOBARBITAL SODIUM | PENTOBARBITAL SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-11-13 | |
Submissions Property Types
TE Codes
CDER Filings
CUSTOPHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203619
[companyName] => CUSTOPHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"PENTOBARBITAL SODIUM","activeIngredients":"PENTOBARBITAL SODIUM","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-11-13
)
)