ANDA 079029

ZYDUS PHARMS USA INC

FDA Drug Application

Application #079029

Documents

• Other Important Information from FDA: 2008-11-13

Application Sponsors

ANDA 079029

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	200MG	0	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
003	TABLET;ORAL	400MG	0	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-09-16
LABELING; Labeling	SUPPL	2	AP	2010-08-31
LABELING; Labeling	SUPPL	3	AP	2013-05-31
LABELING; Labeling	SUPPL	5	AP	2013-05-31
LABELING; Labeling	SUPPL	7	AP	2013-08-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-10-29	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	10	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	22	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79029
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)