Application Sponsors
ANDA 091158 | INVAGEN PHARMS | |
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 100MG | 0 | ORPHENADRINE CITRATE | ORPHENADRINE CITRATE |
FDA Submissions
Submissions Property Types
TE Codes
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 91158
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ORPHENADRINE CITRATE","activeIngredients":"ORPHENADRINE CITRATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ORPHENADRINE CITRATE","submission":"ORPHENADRINE CITRATE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)