Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | RAZADYNE | GALANTAMINE HYDROBROMIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2001-06-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-04-24 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2002-04-19 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2003-09-03 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2005-05-02 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2013-06-28 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2012-03-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2013-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2015-02-09 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2015-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2017-02-14 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 14 | Null | 7 |
SUPPL | 15 | Null | 7 |
SUPPL | 22 | Null | 15 |
SUPPL | 25 | Null | 7 |
SUPPL | 26 | Null | 0 |
SUPPL | 28 | Null | 7 |
SUPPL | 29 | Null | 7 |
SUPPL | 30 | Null | 15 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21224
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"4MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/14\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2015","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021169s031-021224s029-021615s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021169s031-021224s029-021615s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021615s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021169s024,021224s022,021615s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021169s024,021224s022,021615s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s026,021224s025,021615s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s017,021224s015,021615s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s016,021224s014,021615s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21224lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"4MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2017-02-14
)
)