ANDA 083220

PHARMACIA AND UPJOHN

FDA Drug Application

Application #083220

Documents

• Label: 2009-09-30

Application Sponsors

ANDA 083220

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	0.75MG	0	OGEN .625	ESTROPIPATE
002	TABLET;ORAL	1.5MG	0	OGEN 1.25	ESTROPIPATE
003	TABLET;ORAL	3MG	0	OGEN 2.5	ESTROPIPATE
004	TABLET;ORAL	6MG	0	OGEN 5	ESTROPIPATE

FDA Submissions

	ORIG	1	AP	1977-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1992-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-06-01
LABELING; Labeling	SUPPL	24	AP	1992-11-10
LABELING; Labeling	SUPPL	25	AP	1992-04-30
BIOEQUIV; Bioequivalence	SUPPL	31	AP	1991-06-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1997-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1998-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1998-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1998-04-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2001-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2001-09-26
LABELING; Labeling	SUPPL	41	AP	2005-06-09
LABELING; Labeling	SUPPL	42	AP	2015-11-03
LABELING; Labeling	SUPPL	44	AP	2019-05-03	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	31	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	42	Null	7
SUPPL	44	Null	15

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83220
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"OGEN .625","activeIngredients":"ESTROPIPATE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OGEN 1.25","activeIngredients":"ESTROPIPATE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OGEN 2.5","activeIngredients":"ESTROPIPATE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OGEN 5","activeIngredients":"ESTROPIPATE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/09\/2005","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/083220s041lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OGEN .625","submission":"ESTROPIPATE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OGEN 1.25","submission":"ESTROPIPATE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OGEN 2.5","submission":"ESTROPIPATE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OGEN 5","submission":"ESTROPIPATE","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2005-06-09
        )

)