NDA 019617

PHARMACIA AND UPJOHN

FDA Drug Application

Application #019617

Documents

• Letter: 2010-02-22
• Label: 2010-02-16
• Label: 2017-07-06
• Letter: 2017-07-06

Application Sponsors

NDA 019617

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

GEL;ENDOCERVICAL

0.5MG/3GM

1

PREPIDIL

DINOPROSTONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-12-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	1999-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-04-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	2010-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-09-10	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-07-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-02-03	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	10	Null	6
SUPPL	16	Null	0
SUPPL	17	Null	15
SUPPL	18	Null	0

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19617
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREPIDIL","activeIngredients":"DINOPROSTONE","strength":"0.5MG\/3GM","dosageForm":"GEL;ENDOCERVICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/05\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019617s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2010","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019617s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PREPIDIL","submission":"DINOPROSTONE","actionType":"0.5MG\/3GM","submissionClassification":"GEL;ENDOCERVICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-05
        )

)