ANDA 089386

ESI

FDA Drug Application

Application #089386

Application Sponsors

ANDA 089386

ESI

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

CYCRIN

MEDROXYPROGESTERONE ACETATE

FDA Submissions

	ORIG	1	AP	1987-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-02-21
LABELING; Labeling	SUPPL	6	AP	1989-12-06
LABELING; Labeling	SUPPL	7	AP	1990-12-13
BIOEQUIV; Bioequivalence	SUPPL	8	AP	1989-08-21
LABELING; Labeling	SUPPL	9	AP	1992-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-11-28

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89386
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)