ANDA 077771

HIKMA PHARMS

FDA Drug Application

Application #077771

Application Sponsors

ANDA 077771

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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	2011-04-12
LABELING; Labeling	SUPPL	3	AP	2011-11-18
LABELING; Labeling	SUPPL	4	AP	2015-09-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-09-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77771
            [companyName] => HIKMA PHARMS
            [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
        )

)