NDA 020715

ALLERGAN

FDA Drug Application

Application #020715

Documents

• Letter: 2002-01-15
• Letter: 2008-04-16
• Letter: 2011-01-20
• Label: 2013-03-15
• Label: 2014-07-15
• Review: 2002-07-31
• Other Important Information from FDA: 2011-12-20
• Letter: 2000-06-15
• Letter: 2002-01-15
• Letter: 2005-10-25
• Letter: 2011-05-24
• Letter: 2013-03-15
• Letter: 2014-07-15
• Label: 2000-06-15
• Label: 2011-01-20
• Label: 2011-05-23
• Label: 2018-12-18
• Letter: 2018-12-21

Application Sponsors

NDA 020715

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

EQ 3.75MG BASE/VIAL

1

TRELSTAR

TRIPTORELIN PAMOATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2000-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-06-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-01-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2002-01-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2007-02-16	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2008-04-14	N/A
LABELING; Labeling	SUPPL	18	AP	2010-03-16	STANDARD
LABELING; Labeling	SUPPL	24	AP	2011-01-14	901 REQUIRED
LABELING; Labeling	SUPPL	25	AP	2011-05-19	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2013-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2013-06-19	STANDARD
LABELING; Labeling	SUPPL	30	AP	2013-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2014-03-14	STANDARD
LABELING; Labeling	SUPPL	32	AP	2014-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2015-02-03	STANDARD
LABELING; Labeling	SUPPL	40	AP	2018-12-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	13	Null	4
SUPPL	16	Null	4
SUPPL	18	Null	6
SUPPL	24	Null	7
SUPPL	25	Null	31
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	6
SUPPL	31	Null	0
SUPPL	32	Null	15
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	40	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20715
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRELSTAR","activeIngredients":"TRIPTORELIN PAMOATE","strength":"EQ 3.75MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/14\/2018","submission":"SUPPL-40","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-32","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-30","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-25","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-24","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\/15\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20715lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRELSTAR","submission":"TRIPTORELIN PAMOATE","actionType":"EQ 3.75MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-14
        )

)