ANDA 078226

ZYDUS PHARMS USA

FDA Drug Application

Application #078226

Application Sponsors

ANDA 078226

ZYDUS PHARMS USA

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	2007-07-09
LABELING; Labeling	SUPPL	2	AP	2008-02-19
LABELING; Labeling	SUPPL	4	AP	2008-10-14
LABELING; Labeling	SUPPL	6	AP	2010-05-11
LABELING; Labeling	SUPPL	9	AP	2011-05-31
LABELING; Labeling	SUPPL	10	AP	2011-11-28
LABELING; Labeling	SUPPL	11	AP	2014-11-21	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-10-07	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-03-14	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-03-14	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78226
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)