ANDA 206367

INVAGEN PHARMS

FDA Drug Application

Application #206367

Documents

• Letter: 2015-12-16

Application Sponsors

ANDA 206367

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

UNKNOWN;	ORIG	1	AP	2015-12-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-04-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206367
            [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":"12\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206367Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/23\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-04-23
        )

)