NDA 022434

EAGLE PHARMS

FDA Drug Application

Application #022434

Documents

• Letter: 2011-07-06
• Letter: 2014-09-10
• Summary Review: 2011-11-22
• Letter: 2016-05-27
• Label: 2011-06-30
• Label: 2014-09-11
• Label: 2016-06-01
• Review: 2011-11-22
• Letter: 2018-06-21
• Label: 2018-06-22
• Letter: 2019-12-10
• Label: 2019-12-10

Application Sponsors

NDA 022434

EAGLE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/50ML (1MG/ML)

1

ARGATROBAN IN SODIUM CHLORIDE

ARGATROBAN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2011-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2013-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2013-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2014-01-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-08-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-05-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-06-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	13	Null	15

CDER Filings

EAGLE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22434
            [companyName] => EAGLE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN IN SODIUM CHLORIDE","activeIngredients":"ARGATROBAN","strength":"50MG\/50ML (1MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022434s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022434s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022434s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022434s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022434s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARGATROBAN IN SODIUM CHLORIDE","submission":"ARGATROBAN","actionType":"50MG\/50ML (1MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-06
        )

)