PHARMACIA AND UPJOHN FDA Approval NDA 020246

Application #020246

Documents

Letter	2003-06-08
Letter	2004-12-02
Letter	2010-10-19
Letter	2015-02-02
Label	2005-11-01
Label	2003-06-08
Label	2004-12-03
Label	2011-08-05
Label	2015-02-03
Review	2014-08-05
Review	2014-08-05
Review	2014-08-05
Letter	2005-11-01
Letter	2011-08-01
Letter	2015-01-26
Label	2010-10-19
Label	2015-01-29
Review	2014-08-05
Label	2016-12-20
Letter	2016-12-21
Letter	2017-03-20
Review	2017-06-29
Letter	2020-09-10
Label	2020-09-10
Label	2020-09-10
Letter	2020-09-10
Letter	2020-12-08
Letter	2020-12-08
Label	2020-12-10
Label	2020-12-10

Application Sponsors

NDA 020246

PHARMACIA AND UPJOHN

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

DEPO-PROVERA

MEDROXYPROGESTERONE ACETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-10-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-02-17	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1994-12-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	1994-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-02-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-05-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-11-28	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1996-03-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	1997-01-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	1998-08-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2005-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-04-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-06-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-04-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-05-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2003-05-23	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2004-11-17	STANDARD
EFFICACY; Efficacy	SUPPL	35	AP	2011-07-28	STANDARD
EFFICACY; Efficacy	SUPPL	36	AP	2010-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2016-02-24	PRIORITY
LABELING; Labeling	SUPPL	43	AP	2020-09-09	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2013-03-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2013-09-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2013-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2014-06-09	PRIORITY
LABELING; Labeling	SUPPL	53	AP	2015-01-30	STANDARD
LABELING; Labeling	SUPPL	54	AP	2015-01-23	STANDARD
LABELING; Labeling	SUPPL	57	AP	2020-09-09	STANDARD
LABELING; Labeling	SUPPL	58	AP	2016-12-16	STANDARD
EFFICACY; Efficacy	SUPPL	60	AP	2020-12-04	STANDARD
EFFICACY; Efficacy	SUPPL	62	AP	2020-12-04	STANDARD
LABELING; Labeling	SUPPL	63	AP	2017-03-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	35	Null	6
SUPPL	36	Null	6
SUPPL	40	Null	0
SUPPL	43	Null	6
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	15
SUPPL	54	Null	6
SUPPL	57	Null	15
SUPPL	58	Null	7
SUPPL	60	Null	15
SUPPL	62	Null	15
SUPPL	63	Null	7

TE Codes

001

Prescription

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20246
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPO-PROVERA","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/04\/2020","submission":"SUPPL-62","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020246s060s062lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2020","submission":"SUPPL-60","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020246s060s062lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2020","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020246s043s057lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2020","submission":"SUPPL-43","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020246s043s057lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020246s058lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2015","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020246s053lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"SUPPL-54","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020246s054,021583s026lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2011","submission":"SUPPL-35","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020246s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2010","submission":"SUPPL-36","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020246s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020246s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2004","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20246s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2003","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20246scs019_Depo-provera_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"DEPO-PROVERA","submission":"MEDROXYPROGESTERONE ACETATE","actionType":"150MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-12-04
        )

)

NDA 020246

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020246

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

PFIZER