Application Sponsors
ANDA 207264 | SAGENT PHARMS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1MG/ML | 0 | DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-07-11 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SAGENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207264
[companyName] => SAGENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DIHYDROERGOTAMINE MESYLATE","activeIngredients":"DIHYDROERGOTAMINE MESYLATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-07-11
)
)