ANDA 078466

LUPIN PHARMS

FDA Drug Application

Application #078466

Application Sponsors

ANDA 078466

LUPIN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	CAPSULE;ORAL	EQ 2.5MG BASE;10MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 5MG BASE;10MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 5MG BASE;20MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 10MG BASE;20MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
005	CAPSULE;ORAL	EQ 5MG BASE;40MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
006	CAPSULE;ORAL	EQ 10MG BASE;40MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
007	CAPSULE; ORAL	10MG; 40MG	0	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-02-05
	ORIG	2	AP	2011-07-05
LABELING; Labeling	SUPPL	5	AP	2010-10-04
LABELING; Labeling	SUPPL	6	AP	2011-08-31
LABELING; Labeling	SUPPL	8	AP	2012-09-27
LABELING; Labeling	SUPPL	9	AP	2014-11-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-12-03	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-12-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-12-03	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	20	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78466
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 2.5MG BASE;10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE;10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE;20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 10MG BASE;20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 10MG BASE;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"10MG; 40MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 2.5MG BASE;10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE;10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE;20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 10MG BASE;20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 10MG BASE;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"10MG; 40MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)