ANDA 090011

PAR PHARM INC

FDA Drug Application

Application #090011

Documents

• Letter: 2013-04-02

Application Sponsors

ANDA 090011

PAR PHARM INC

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

	ORIG	1	AP	2013-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-11-14	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2016-02-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-02-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

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

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90011
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 5MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 10MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 5MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 10MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE AND VALSARTAN","submission":"AMLODIPINE BESYLATE; VALSARTAN","actionType":"EQ 5MG BASE;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND VALSARTAN","submission":"AMLODIPINE BESYLATE; VALSARTAN","actionType":"EQ 10MG BASE;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND VALSARTAN","submission":"AMLODIPINE BESYLATE; VALSARTAN","actionType":"EQ 5MG BASE;320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND VALSARTAN","submission":"AMLODIPINE BESYLATE; VALSARTAN","actionType":"EQ 10MG BASE;320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)