NDA 022437

ALLERGAN

FDA Drug Application

Application #022437

Documents

• Letter: 2010-03-18
• Letter: 2014-07-15
• Label: 2011-05-23
• Label: 2013-03-15
• Label: 2014-07-15
• Summary Review: 2011-02-17
• Letter: 2011-01-20
• Letter: 2011-05-24
• Letter: 2013-03-15
• Label: 2010-03-17
• Label: 2011-01-20
• Review: 2010-11-10
• Other Important Information from FDA: 2011-12-20
• Label: 2018-12-18
• Letter: 2018-12-21

Application Sponsors

NDA 022437

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

EQ 22.5MG BASE/VIAL

1

TRELSTAR

TRIPTORELIN PAMOATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-03-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2011-01-14	901 REQUIRED
LABELING; Labeling	SUPPL	3	AP	2011-05-19	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2013-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2013-04-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-03-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-01-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-01-26	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-12-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	15
SUPPL	8	Null	6
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22437
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRELSTAR","activeIngredients":"TRIPTORELIN PAMOATE","strength":"EQ 22.5MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/14\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020715s040,021288s035,022427s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020715s032,021288s028,022437s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020715s030,021288s027,022437s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020715s025,021288s022,022437s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020715s024,021288s021,022437s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022437lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRELSTAR","submission":"TRIPTORELIN PAMOATE","actionType":"EQ 22.5MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-14
        )

)