Documents
Application Sponsors
Marketing Status
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
)
)