NDA 021224

JANSSEN PHARMS

FDA Drug Application

Application #021224

Documents

• Letter: 2001-06-22
• Letter: 2002-05-02
• Letter: 2003-09-09
• Letter: 2005-05-03
• Letter: 2006-05-01
• Letter: 2006-05-01
• Letter: 2012-03-05
• Letter: 2013-07-02
• Letter: 2012-03-05
• Letter: 2015-02-12
• Label: 2001-06-22
• Label: 2012-03-06
• Label: 2013-07-11
• Label: 2015-12-17
• Review: 2002-03-05
• Other Important Information from FDA: 2005-07-29
• Letter: 2006-05-01
• Letter: 2006-05-01
• Letter: 2012-03-05
• Letter: 2015-12-17
• Label: 2012-03-06
• Label: 2012-05-01
• Label: 2015-02-10
• Letter: 2017-02-16
• Label: 2017-02-16

Application Sponsors

NDA 021224

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

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4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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HYDROBROMIDE","strength":"4MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]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
        )

)