ANDA 040412

PRINSTON INC

FDA Drug Application

Application #040412

Documents

• Letter: 2003-04-09

Application Sponsors

ANDA 040412

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	50MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	2002-03-29
LABELING; Labeling	SUPPL	11	AP	2011-12-31
LABELING; Labeling	SUPPL	23	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	23	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40412
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)