NDA 020472

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020472

Documents

• Letter: 2014-08-14
• Letter: 2015-09-30
• Label: 2015-12-10
• Review: 2009-01-12
• Review: 2009-01-12
• Letter: 2008-08-27
• Letter: 2015-09-30
• Label: 2008-08-29
• Label: 2014-08-13
• Label: 2015-12-10
• Review: 2009-01-12
• Label: 2017-11-02
• Letter: 2017-11-06
• Letter: 2019-01-03
• Letter: 2022-07-28
• Label: 2022-08-05

Application Sponsors

NDA 020472

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INSERT, EXTENDED RELEASE;VAGINAL

0.0075MG/24HR

1

ESTRING

ESTRADIOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-04-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-01-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-07-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2008-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-05-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-08-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-11-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-07-27	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	19	Null	15

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20472
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRING","activeIngredients":"ESTRADIOL","strength":"0.0075MG\/24HR","dosageForm":"INSERT, EXTENDED RELEASE;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020472s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020472s012s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020472s012s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020472s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020472s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ESTRING","submission":"ESTRADIOL","actionType":"0.0075MG\/24HR","submissionClassification":"INSERT, EXTENDED RELEASE;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-11-01
        )

)