ANDA 040190

ELITE LABS INC

FDA Drug Application

Application #040190

Application Sponsors

ANDA 040190

ELITE LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

37.5MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-05-30
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
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2013-11-08
LABELING; Labeling	SUPPL	17	AP	2017-05-31	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	15	Null	15
SUPPL	17	Null	15

TE Codes

001

Prescription

AA

CDER Filings

ELITE LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40190
            [companyName] => ELITE LABS 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
        )

)