ANDA 040227

ELITE LABS INC

FDA Drug Application

Application #040227

Documents

• Review: 2011-02-18

Application Sponsors

ANDA 040227

ELITE LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

30MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-06-18
LABELING; Labeling	SUPPL	2	AP	1999-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-11-14
LABELING; Labeling	SUPPL	10	AP	2017-05-31	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	10	Null	7

CDER Filings

ELITE LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40227
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)