Documents
Application Sponsors
ANDA 207686 | PRECISION DOSE INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5MG/VIAL | 0 | PHENTOLAMINE MESYLATE | PHENTOLAMINE MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-07-14 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
PRECISION DOSE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207686
[companyName] => PRECISION DOSE INC
[docInserts] => ["",""]
[products] => [{"drugName":"PHENTOLAMINE MESYLATE","activeIngredients":"PHENTOLAMINE MESYLATE","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-07-14
)
)