ANDA 077183

DR REDDYS LABS INC

FDA Drug Application

Application #077183

Application Sponsors

ANDA 077183

DR REDDYS LABS INC

Marketing Status

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

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

FDA Submissions

	ORIG	1	AP	2010-04-15
LABELING; Labeling	SUPPL	2	AP	2011-02-14
LABELING; Labeling	SUPPL	3	AP	2011-10-27
LABELING; Labeling	SUPPL	4	AP	2011-12-12
LABELING; Labeling	SUPPL	5	AP	2012-02-23
LABELING; Labeling	SUPPL	6	AP	2014-10-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15

TE Codes

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

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77183
            [companyName] => DR REDDYS LABS INC
            [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"}]
            [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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)