ANDA 207686

PRECISION DOSE INC

FDA Drug Application

Application #207686

Documents

• Review: 2022-06-28

Application Sponsors

ANDA 207686

PRECISION DOSE INC

Marketing Status

• Prescription: 001

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

ORIG

1

Null

15

TE Codes

001

Prescription

AP

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
        )

)