ANDA 076217

MYLAN INSTITUTIONAL

FDA Drug Application

Application #076217

Documents

• Other Important Information from FDA: 2005-07-28

Application Sponsors

ANDA 076217

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-10-15
LABELING; Labeling	SUPPL	3	AP	2003-11-14
LABELING; Labeling	SUPPL	5	AP	2004-01-05
LABELING; Labeling	SUPPL	11	AP	2006-02-01
LABELING; Labeling	SUPPL	12	AP	2007-10-15
LABELING; Labeling	SUPPL	13	AP	2008-03-24
LABELING; Labeling	SUPPL	17	AP	2009-06-24
LABELING; Labeling	SUPPL	33	AP	2020-06-23	STANDARD

Submissions Property Types

SUPPL

33

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76217
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)