ANDA 040907

UNICHEM

FDA Drug Application

Application #040907

Application Sponsors

ANDA 040907

UNICHEM

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	2008-08-15
LABELING; Labeling	SUPPL	4	AP	2011-11-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2016-03-07	UNKNOWN
LABELING; Labeling	SUPPL	18	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	9	Null	7
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UNICHEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40907
            [companyName] => UNICHEM
            [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
        )

)