ANDA 088342

UPSHER SMITH LABS

FDA Drug Application

Application #088342

Application Sponsors

ANDA 088342

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

FLUOXYMESTERONE

FLUOXYMESTERONE

FDA Submissions

	ORIG	1	AP	1983-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-12-26
LABELING; Labeling	SUPPL	19	AP	1989-01-12
LABELING; Labeling	SUPPL	20	AP	1989-11-07
LABELING; Labeling	SUPPL	21	AP	1990-03-08
LABELING; Labeling	SUPPL	22	AP	1991-07-02
LABELING; Labeling	SUPPL	24	AP	1991-12-11
LABELING; Labeling	SUPPL	25	AP	1992-04-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88342
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXYMESTERONE","activeIngredients":"FLUOXYMESTERONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXYMESTERONE","submission":"FLUOXYMESTERONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)