ANDA 085470

PHARMACIA AND UPJOHN

FDA Drug Application

Application #085470

Documents

• Label: 2009-09-30

Application Sponsors

ANDA 085470

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	1MG/ML	0	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE
002	INJECTABLE;INJECTION	3MG/ML	0	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE
003	INJECTABLE;INJECTION	5MG/ML	0	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE

FDA Submissions

	ORIG	1	AP	1979-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-07-01
LABELING; Labeling	SUPPL	10	AP	1998-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-05-28
LABELING; Labeling	SUPPL	15	AP	2005-06-15
LABELING; Labeling	SUPPL	23	AP	2019-05-03	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	23	Null	7

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85470
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPO-ESTRADIOL","activeIngredients":"ESTRADIOL CYPIONATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEPO-ESTRADIOL","activeIngredients":"ESTRADIOL CYPIONATE","strength":"3MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEPO-ESTRADIOL","activeIngredients":"ESTRADIOL CYPIONATE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/15\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/085470s015lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEPO-ESTRADIOL","submission":"ESTRADIOL CYPIONATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEPO-ESTRADIOL","submission":"ESTRADIOL CYPIONATE","actionType":"3MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEPO-ESTRADIOL","submission":"ESTRADIOL CYPIONATE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-06-15
        )

)