ANDA 040377

PRINSTON INC

FDA Drug Application

Application #040377

Documents

• Letter: 2002-01-04

Application Sponsors

ANDA 040377

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

37.5MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-01-04
LABELING; Labeling	SUPPL	7	AP	2012-12-06	STANDARD
LABELING; Labeling	SUPPL	11	AP	2012-12-06	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-05-31	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	11	Null	7
SUPPL	14	Null	15

TE Codes

001

Prescription

AA

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
        )

)