ANDA 205137

INVAGEN PHARMS

FDA Drug Application

Application #205137

Application Sponsors

ANDA 205137

INVAGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE;160MG	0	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN
002	TABLET;ORAL	EQ 10MG BASE;160MG	0	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN
003	TABLET;ORAL	EQ 5MG BASE;320MG	0	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN
004	TABLET;ORAL	EQ 10MG BASE;320MG	0	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205137
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 5MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 10MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 5MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 10MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-16
        )

)