ANDA 084325

LANNETT CO INC

FDA Drug Application

Application #084325

Application Sponsors

ANDA 084325

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1976-06-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1982-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1982-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1983-11-22
BIOEQUIV; Bioequivalence	SUPPL	34	AP	1989-03-08
LABELING; Labeling	SUPPL	35	AP	2007-08-06
LABELING; Labeling	SUPPL	38	AP	2008-03-06
LABELING; Labeling	SUPPL	44	AP	2011-08-18
LABELING; Labeling	SUPPL	49	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	34	Null	0
SUPPL	44	Null	15
SUPPL	49	Null	7

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84325
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)