Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | EQ 4MG BASE | 1 | RAZADYNE | GALANTAMINE HYDROBROMIDE |
002 | TABLET;ORAL | EQ 8MG BASE | 1 | RAZADYNE | GALANTAMINE HYDROBROMIDE |
003 | TABLET;ORAL | EQ 12MG BASE | 1 | RAZADYNE | GALANTAMINE HYDROBROMIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2001-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2002-04-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-07-31 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2003-09-03 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2005-05-02 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2013-06-28 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2012-03-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2013-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2015-02-09 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2015-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2017-02-14 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2020-03-20 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2021-08-03 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 16 | Null | 7 |
SUPPL | 17 | Null | 7 |
SUPPL | 24 | Null | 15 |
SUPPL | 26 | Null | 15 |
SUPPL | 28 | Null | 0 |
SUPPL | 30 | Null | 7 |
SUPPL | 31 | Null | 7 |
SUPPL | 32 | Null | 15 |
SUPPL | 33 | Null | 6 |
SUPPL | 34 | Null | 15 |
SUPPL | 35 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21169
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/03\/2021","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021169s035,021615s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021169s034lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021169s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021169s033,021615s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2017","submission":"SUPPL-32","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-31","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-30","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-24","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-26","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-17","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-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s016,021224s014,021615s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21169lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 12MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-08-03
)
)