ANDA 089743

LANNETT CO INC

FDA Drug Application

Application #089743

Application Sponsors

ANDA 089743

LANNETT CO INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	10MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE
002	TABLET;ORAL	1MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE
003	TABLET;ORAL	2.5MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE
004	TABLET;ORAL	5MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-08-25
BIOEQUIV; Bioequivalence	SUPPL	8	AP	1992-11-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-11-26
LABELING; Labeling	SUPPL	11	AP	1993-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-08-16
LABELING; Labeling	SUPPL	21	AP	2008-07-25
LABELING; Labeling	SUPPL	22	AP	2009-01-23
LABELING; Labeling	SUPPL	23	AP	2010-03-12
LABELING; Labeling	SUPPL	25	AP	2010-12-03
LABELING; Labeling	SUPPL	28	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	7
SUPPL	25	Null	7
SUPPL	28	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89743
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)