ANDA 078652

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078652

Application Sponsors

ANDA 078652

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	CAPSULE; ORAL	2.5MG; 10MG	0	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
002	CAPSULE; ORAL	5MG; 10MG	0	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
003	CAPSULE; ORAL	5MG; 20MG	0	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
004	CAPSULE; ORAL	10MG; 20MG	0	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

FDA Submissions

ORIG

1

TA

2013-03-28

Submissions Property Types

ORIG

1

Null

19

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78652
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"2.5MG; 10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"5MG; 10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"5MG; 20MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"10MG; 20MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"2.5MG; 10MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"5MG; 10MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"5MG; 20MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"10MG; 20MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)