ANDA 091374

AM REGENT

FDA Drug Application

Application #091374

Application Sponsors

ANDA 091374

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.004MG/ML

0

DESMOPRESSIN ACETATE

DESMOPRESSIN ACETATE

FDA Submissions

ORIG

1

AP

2019-02-14

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91374
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.004MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESMOPRESSIN ACETATE","submission":"DESMOPRESSIN ACETATE","actionType":"0.004MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)