NDA 020630

MYLAN INSTITUTIONAL

FDA Drug Application

Application #020630

Documents

• Label: 2004-04-05
• Letter: 2004-03-10
• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2018-07-04
• Review: 2019-02-15
• Letter: 2019-10-09
• Label: 2019-10-15

Application Sponsors

NDA 020630

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	1	ULTIVA	REMIFENTANIL HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 2MG BASE/VIAL	1	ULTIVA	REMIFENTANIL HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 5MG BASE/VIAL	1	ULTIVA	REMIFENTANIL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-07-12	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1999-11-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	1999-06-23	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2004-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2013-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-01-12	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-06-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-10-07	STANDARD

Submissions Property Types

SUPPL	5	Null	6
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	20	Null	6

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20630
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTIVA","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 1MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ULTIVA","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 2MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ULTIVA","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020630s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020630s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020630s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020630s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020630s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2004","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20630se5-005_ultiva_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULTIVA","submission":"REMIFENTANIL HYDROCHLORIDE","actionType":"EQ 1MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ULTIVA","submission":"REMIFENTANIL HYDROCHLORIDE","actionType":"EQ 2MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ULTIVA","submission":"REMIFENTANIL HYDROCHLORIDE","actionType":"EQ 5MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)