ANDA 078477

AMNEAL PHARMS NY

FDA Drug Application

Application #078477

Application Sponsors

ANDA 078477

AMNEAL PHARMS NY

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	EQ 2.5MG BASE	0	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
002	TABLET;ORAL	EQ 5MG BASE	0	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
003	TABLET;ORAL	EQ 10MG BASE	0	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE

FDA Submissions

	ORIG	1	AP	2008-01-16
LABELING; Labeling	SUPPL	5	AP	2011-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2011-11-01
LABELING; Labeling	SUPPL	9	AP	2010-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2011-11-01
LABELING; Labeling	SUPPL	13	AP	2011-07-26
LABELING; Labeling	SUPPL	16	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-11-24	STANDARD
LABELING; Labeling	SUPPL	19	AP	2018-04-05	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	12	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78477
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)