Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | EQ 8MG BASE | 1 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | EQ 16MG BASE | 1 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE |
003 | CAPSULE, EXTENDED RELEASE;ORAL | EQ 24MG BASE | 1 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-04-01 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2005-05-02 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2006-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2013-06-28 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2012-03-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2013-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2015-02-09 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2015-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2017-02-14 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2020-03-20 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2021-08-03 | STANDARD |
LABELING; Labeling | SUPPL | 27 | AP | 2022-09-26 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 31 |
SUPPL | 8 | Null | 6 |
SUPPL | 9 | Null | 6 |
SUPPL | 16 | Null | 7 |
SUPPL | 18 | Null | 7 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 7 |
SUPPL | 22 | Null | 15 |
SUPPL | 23 | Null | 6 |
SUPPL | 24 | Null | 6 |
SUPPL | 25 | Null | 15 |
SUPPL | 26 | Null | 7 |
SUPPL | 27 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21615
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RAZADYNE ER","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 8MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"RAZADYNE ER","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 16MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RAZADYNE ER","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 24MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/03\/2021","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021169s035,021615s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2020","submission":"SUPPL-24","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-23","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-22","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-22","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-21","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-16","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-16","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-18","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-9","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-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s016,021224s014,021615s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021615lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RAZADYNE ER","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 8MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RAZADYNE ER","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 16MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RAZADYNE ER","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 24MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-08-03
)
)