ANDA 077161

GLAND PHARMA LTD

FDA Drug Application

Application #077161

Documents

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

Application Sponsors

ANDA 077161

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-04-20
LABELING; Labeling	SUPPL	3	AP	2008-08-22
LABELING; Labeling	SUPPL	4	AP	2009-01-15
LABELING; Labeling	SUPPL	5	AP	2009-11-20
LABELING; Labeling	SUPPL	6	AP	2010-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-05-21
LABELING; Labeling	SUPPL	10	AP	2020-06-23	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	19
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77161
            [companyName] => GLAND PHARMA LTD
            [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
        )

)