ANDA 075389

MAYNE PHARMA INC

FDA Drug Application

Application #075389

Documents

• Letter: 2001-01-25
• Other Important Information from FDA: 2005-07-28

Application Sponsors

ANDA 075389

MAYNE PHARMA 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	2001-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-08-23
LABELING; Labeling	SUPPL	3	AP	2002-08-28
LABELING; Labeling	SUPPL	4	AP	2005-05-03
LABELING; Labeling	SUPPL	6	AP	2007-03-07
LABELING; Labeling	SUPPL	7	AP	2007-04-12
LABELING; Labeling	SUPPL	8	AP	2008-02-21
LABELING; Labeling	SUPPL	12	AP	2019-11-21	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	12	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75389
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"400MG","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"},{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)