ANDA 088484

UPSHER SMITH LABS

FDA Drug Application

Application #088484

Application Sponsors

ANDA 088484

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

MEDROXYPROGESTERONE ACETATE

MEDROXYPROGESTERONE ACETATE

FDA Submissions

	ORIG	1	AP	1984-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1986-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1988-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1988-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1988-06-16
LABELING; Labeling	SUPPL	23	AP	1989-03-15
LABELING; Labeling	SUPPL	24	AP	1989-06-27
LABELING; Labeling	SUPPL	25	AP	1989-08-04
LABELING; Labeling	SUPPL	27	AP	1991-03-15
LABELING; Labeling	SUPPL	28	AP	1992-06-19
LABELING; Labeling	SUPPL	29	AP	1992-09-10
LABELING; Labeling	SUPPL	30	AP	1995-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1995-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1995-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-12-01

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88484
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDROXYPROGESTERONE ACETATE","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEDROXYPROGESTERONE ACETATE","submission":"MEDROXYPROGESTERONE ACETATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)