ANDA 076230

PRINSTON INC

FDA Drug Application

Application #076230

Application Sponsors

ANDA 076230

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG;10MG	0	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL
002	TABLET;ORAL	12.5MG;20MG	0	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL
003	TABLET;ORAL	25MG;20MG	0	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL

FDA Submissions

	ORIG	1	AP	2002-07-01
LABELING; Labeling	SUPPL	2	AP	2003-05-13
LABELING; Labeling	SUPPL	5	AP	2004-10-20
LABELING; Labeling	SUPPL	19	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL

19

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76230
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"25MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"25MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)