NDA 021057

ORGANON USA INC

FDA Drug Application

Application #021057

Documents

• Letter: 1999-07-29
• Letter: 2008-07-02
• Letter: 2014-12-23
• Label: 1999-07-29
• Label: 2008-06-30
• Label: 2015-01-09
• Review: 2004-05-27
• Label: 2020-10-30
• Letter: 2021-01-07

Application Sponsors

NDA 021057

ORGANON USA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MCG/0.5ML

1

GANIRELIX ACETATE

GANIRELIX ACETATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-07-29	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2001-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-20	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2008-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2016-03-10	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2014-12-19	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-01-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-05-03	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2020-10-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	6
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21057
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANIRELIX ACETATE","activeIngredients":"GANIRELIX ACETATE","strength":"250MCG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/19\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021057s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021057s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/21057lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GANIRELIX ACETATE","submission":"GANIRELIX ACETATE","actionType":"250MCG\/0.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-12-19
        )

)