ANDA 088430

UPSHER SMITH LABS

FDA Drug Application

Application #088430

Application Sponsors

ANDA 088430

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

30MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-08-24
LABELING; Labeling	SUPPL	19	AP	1989-10-18

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88430
            [companyName] => UPSHER SMITH LABS
            [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
        )

)