ANDA 085635

PHARMACIA AND UPJOHN

FDA Drug Application

Application #085635

Documents

• Label: 2014-07-16
• Label: 2015-05-12
• Review: 2014-08-06
• Review: 2014-08-06
• Review: 2014-08-06
• Label: 2019-02-12

Application Sponsors

ANDA 085635

PHARMACIA AND UPJOHN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	50MG/ML	0	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE
002	INJECTABLE;INJECTION	100MG/ML	0	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE
003	INJECTABLE;INJECTION	200MG/ML	0	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE

FDA Submissions

	ORIG	1	AP	1979-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-06-13
LABELING; Labeling	SUPPL	11	AP	1991-07-11
LABELING; Labeling	SUPPL	12	AP	1996-05-03
LABELING; Labeling	SUPPL	13	AP	1997-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-05-28
LABELING; Labeling	SUPPL	26	AP	2015-02-17	STANDARD
LABELING; Labeling	SUPPL	29	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	30	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	32	AP	2016-08-12	STANDARD
LABELING; Labeling	SUPPL	35	AP	2016-10-25	STANDARD
LABELING; Labeling	SUPPL	38	AP	2017-01-09	STANDARD
LABELING; Labeling	SUPPL	40	AP	2018-08-01	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	26	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	15
SUPPL	32	Null	15
SUPPL	35	Null	7
SUPPL	38	Null	15
SUPPL	40	Null	15

TE Codes

002	Prescription	AO
003	Prescription	AO

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85635
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPO-TESTOSTERONE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEPO-TESTOSTERONE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DEPO-TESTOSTERONE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/01\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/085635s040lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/085635s040lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/085635s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/085635s029lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEPO-TESTOSTERONE","submission":"TESTOSTERONE CYPIONATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEPO-TESTOSTERONE","submission":"TESTOSTERONE CYPIONATE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEPO-TESTOSTERONE","submission":"TESTOSTERONE CYPIONATE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-08-01
        )

)