ANDA 084324

LANNETT CO INC

FDA Drug Application

Application #084324

Application Sponsors

ANDA 084324

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1976-06-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1982-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1982-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1983-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1983-11-22
BIOEQUIV; Bioequivalence	SUPPL	54	AP	1989-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1989-06-15
LABELING; Labeling	SUPPL	56	AP	2007-08-06
LABELING; Labeling	SUPPL	59	AP	2008-03-06
LABELING; Labeling	SUPPL	65	AP	2011-08-18
LABELING; Labeling	SUPPL	70	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	65	Null	15
SUPPL	70	Null	7

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84324
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)