NDA 021288

ALLERGAN

FDA Drug Application

Application #021288

Documents

• Letter: 2001-06-29
• Letter: 2008-04-16
• Letter: 2011-01-20
• Letter: 2013-03-15
• Label: 2011-01-20
• Label: 2014-07-15
• Review: 2002-01-07
• Letter: 2005-10-25
• Letter: 2011-05-24
• Letter: 2014-07-15
• Label: 2001-06-29
• Label: 2011-05-23
• Label: 2013-03-15
• Other Important Information from FDA: 2011-12-20
• Label: 2018-12-18
• Letter: 2018-12-21

Application Sponsors

NDA 021288

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

EQ 11.25MG BASE/VIAL

1

TRELSTAR

TRIPTORELIN PAMOATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-06-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2005-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2007-02-16	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2008-04-14	N/A
LABELING; Labeling	SUPPL	15	AP	2010-03-17	STANDARD
LABELING; Labeling	SUPPL	21	AP	2011-01-14	901 REQUIRED
LABELING; Labeling	SUPPL	22	AP	2011-05-19	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2013-04-25	STANDARD
LABELING; Labeling	SUPPL	27	AP	2013-03-12	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2014-07-15	STANDARD
LABELING; Labeling	SUPPL	35	AP	2018-12-14	STANDARD

Submissions Property Types

SUPPL	9	Null	4
SUPPL	13	Null	4
SUPPL	15	Null	6
SUPPL	21	Null	7
SUPPL	22	Null	31
SUPPL	24	Null	0
SUPPL	27	Null	6
SUPPL	28	Null	6
SUPPL	29	Null	0
SUPPL	35	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21288
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRELSTAR","activeIngredients":"TRIPTORELIN PAMOATE","strength":"EQ 11.25MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/14\/2018","submission":"SUPPL-35","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-28","supplementCategories":"Labeling-Container\/Carton Labels","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-27","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-22","supplementCategories":"Labeling-Package Insert","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-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020715s024,021288s021,022437s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21288lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRELSTAR","submission":"TRIPTORELIN PAMOATE","actionType":"EQ 11.25MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-14
        )

)