ANDA 077955

INVAGEN PHARMS

FDA Drug Application

Application #077955

Application Sponsors

ANDA 077955

INVAGEN 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	2007-08-28
LABELING; Labeling	SUPPL	2	AP	2011-02-11
LABELING; Labeling	SUPPL	3	AP	2013-08-26
LABELING; Labeling	SUPPL	5	AP	2013-08-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-08-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-12-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-04-20	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	3	Null	8
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77955
            [companyName] => INVAGEN PHARMS
            [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
        )

)