ANDA 078385

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078385

Application Sponsors

ANDA 078385

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	12.5MG;50MG	0	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
002	TABLET;ORAL	25MG;100MG	0	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

FDA Submissions

	ORIG	1	AP	2010-10-06
LABELING; Labeling	SUPPL	6	AP	2011-09-21
LABELING; Labeling	SUPPL	7	AP	2013-01-28
LABELING; Labeling	SUPPL	8	AP	2013-03-08
LABELING; Labeling	SUPPL	9	AP	2013-02-20	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-11-06	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-08-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-07-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-07-08	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-02-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78385
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"12.5MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","actionType":"12.5MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","actionType":"25MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)