PRINSTON INC FDA Approval ANDA 040377

ANDA 040377

PRINSTON INC

FDA Drug Application

Application #040377

Documents

Letter2002-01-04

Application Sponsors

ANDA 040377PRINSTON INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL37.5MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2002-01-04
LABELING; LabelingSUPPL7AP2012-12-06STANDARD
LABELING; LabelingSUPPL11AP2012-12-06STANDARD
LABELING; LabelingSUPPL14AP2017-05-31STANDARD

Submissions Property Types

SUPPL7Null15
SUPPL11Null7
SUPPL14Null15

TE Codes

001PrescriptionAA

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40377
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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