NDA 018045

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018045

Documents

• Letter: 2002-01-18
• Letter: 2003-10-29
• Letter: 2008-07-14
• Label: 2003-10-31
• Label: 2008-07-10

Application Sponsors

NDA 018045

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 140MG PHOSPHATE

1

EMCYT

ESTRAMUSTINE PHOSPHATE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1981-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-04-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	1984-10-22
LABELING; Labeling	SUPPL	5	AP	1987-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-02-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	1998-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-01-11	STANDARD
LABELING; Labeling	SUPPL	16	AP	2002-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-09-07	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-10-28	STANDARD
LABELING; Labeling	SUPPL	23	AP	2008-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-02-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	28	Null	0

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18045
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMCYT","activeIngredients":"ESTRAMUSTINE PHOSPHATE SODIUM","strength":"EQ 140MG PHOSPHATE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/09\/2008","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018045s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/18045slr021_emcyt_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EMCYT","submission":"ESTRAMUSTINE PHOSPHATE SODIUM","actionType":"EQ 140MG PHOSPHATE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-07-09
        )

)