NDA 020491

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020491

Documents

• Letter: 1999-05-13
• Letter: 2001-04-20
• Label: 2001-04-20
• Review: 1999-05-13
• Review: 1998-04-03
• Review: 2001-04-20
• Label: 1999-05-13
• Review: 1996-03-16

Application Sponsors

NDA 020491

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.1MG/ML

1

CORVERT

IBUTILIDE FUMARATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1995-12-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1998-04-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2001-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-06-09	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20491
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CORVERT","activeIngredients":"IBUTILIDE FUMARATE","strength":"0.1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/20\/2001","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-491S003.pdf\"}]","notes":""},{"actionDate":"05\/13\/1999","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20491s01lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CORVERT","submission":"IBUTILIDE FUMARATE","actionType":"0.1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2001-04-20
        )

)