NDA 017968

PHARMACIA AND UPJOHN

FDA Drug Application

Application #017968

Application Sponsors

NDA 017968

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML;50MG/ML

0

DEPO-TESTADIOL

ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-04-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	1985-06-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	1993-05-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	1996-02-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	1994-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-05-23	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17968
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPO-TESTADIOL","activeIngredients":"ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE","strength":"2MG\/ML;50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEPO-TESTADIOL","submission":"ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE","actionType":"2MG\/ML;50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)