ANDA 075907

PRINSTON INC

FDA Drug Application

Application #075907

Documents

• Review: 2005-07-22

Application Sponsors

ANDA 075907

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

12.5MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	2002-09-17
LABELING; Labeling	SUPPL	6	AP	2011-07-07
LABELING; Labeling	SUPPL	15	AP	2022-06-06	STANDARD

Submissions Property Types

SUPPL

15

Null

31

TE Codes

001

Prescription

AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75907
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"12.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"12.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)