ANDA 090364

WATSON LABS INC

FDA Drug Application

Application #090364

Application Sponsors

ANDA 090364

WATSON LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 5MG BASE;40MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 10MG BASE;40MG	0	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-07-05
LABELING; Labeling	SUPPL	2	AP	2012-09-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-04-17	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-04-17	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-04-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	6	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90364
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"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"}]
            [labels] => 
            [originalApprovals] => [{"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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)