ANDA 091451

NOVAST LABS

FDA Drug Application

Application #091451

Application Sponsors

ANDA 091451

NOVAST LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

37.5MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-09-21
LABELING; Labeling	SUPPL	2	AP	2017-05-31	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91451
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)