NDA 020193

JANSSEN PHARMS

FDA Drug Application

Application #020193

Documents

• Letter: 2006-09-25
• Letter: 2008-12-23
• Label: 2009-01-02
• Letter: 2004-08-25
• Letter: 2008-07-29
• Label: 2004-08-25
• Label: 2006-09-21
• Label: 2008-07-29
• Review: 2012-05-09
• Review: 2019-02-15
• Letter: 2020-06-17
• Label: 2020-06-17
• Review: 2021-01-06
• Label: 2021-03-15
• Medication Guide: 2021-03-15
• Letter: 2021-03-16
• Review: 2021-09-24

Application Sponsors

NDA 020193

JANSSEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

1

ELMIRON

PENTOSAN POLYSULFATE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-11-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2004-08-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2006-09-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2008-07-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2008-12-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-06-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-03-12	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	14	Null	7
SUPPL	15	Null	15

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20193
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/020193s015lbl.pdf#page=11"]
            [products] => [{"drugName":"ELMIRON","activeIngredients":"PENTOSAN POLYSULFATE SODIUM","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/12\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020193Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020193Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020193s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2008","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020193s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020193s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2006","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020193s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2004","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20193s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ELMIRON","submission":"PENTOSAN POLYSULFATE SODIUM","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-03-12
        )

)