ANDA 084487

UPSHER SMITH LABS

FDA Drug Application

Application #084487

Application Sponsors

ANDA 084487

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

30MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1982-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-04-05
LABELING; Labeling	SUPPL	18	AP	1989-09-22
LABELING; Labeling	SUPPL	19	AP	1991-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-09-17

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84487
            [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
        )

)