NDA 017989

PHARMACIA AND UPJOHN

FDA Drug Application

Application #017989

Documents

• Letter: 2013-12-13
• Label: 2013-12-17

Application Sponsors

NDA 017989

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.25MG BASE/ML

1

HEMABATE

CARBOPROST TROMETHAMINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1979-01-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	1980-03-20
LABELING; Labeling	SUPPL	3	AP	1981-12-29
LABELING; Labeling	SUPPL	4	AP	1983-08-30
LABELING; Labeling	SUPPL	5	AP	1985-05-21
LABELING; Labeling	SUPPL	6	AP	1986-09-08
LABELING; Labeling	SUPPL	7	AP	1988-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-05-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	1995-08-29	STANDARD
LABELING; Labeling	SUPPL	11	AP	1995-08-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	1998-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-10-15	STANDARD
LABELING; Labeling	SUPPL	19	AP	2013-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2014-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2015-06-19	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	19	Null	15
SUPPL	22	Null	0
SUPPL	23	Null	0

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17989
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEMABATE","activeIngredients":"CARBOPROST TROMETHAMINE","strength":"EQ 0.25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2013","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017989s019lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HEMABATE","submission":"CARBOPROST TROMETHAMINE","actionType":"EQ 0.25MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-12-11
        )

)