ANDA 084113

UPSHER SMITH LABS

FDA Drug Application

Application #084113

Application Sponsors

ANDA 084113

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1974-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1982-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1984-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1985-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1986-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1986-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1986-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1987-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	1987-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1987-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1988-04-14
LABELING; Labeling	SUPPL	80	AP	1988-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	1988-07-08
LABELING; Labeling	SUPPL	82	AP	1988-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1989-02-14
LABELING; Labeling	SUPPL	84	AP	1990-11-29
LABELING; Labeling	SUPPL	85	AP	1991-12-31
LABELING; Labeling	SUPPL	86	AP	1992-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1996-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1999-03-22
LABELING; Labeling	SUPPL	89	AP	1999-03-22
LABELING; Labeling	SUPPL	90	AP	2002-11-25
LABELING; Labeling	SUPPL	105	AP	2008-11-19
LABELING; Labeling	SUPPL	108	AP	2009-08-24
LABELING; Labeling	SUPPL	111	AP	2010-12-03
LABELING; Labeling	SUPPL	114	AP	2011-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	118	AP	2016-08-29	UNKNOWN
LABELING; Labeling	SUPPL	119	AP	2017-02-23	STANDARD
LABELING; Labeling	SUPPL	122	AP	2020-02-05	STANDARD

Submissions Property Types

SUPPL	63	Null	0
SUPPL	65	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	76	Null	0
SUPPL	79	Null	0
SUPPL	81	Null	0
SUPPL	83	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	108	Null	7
SUPPL	111	Null	7
SUPPL	114	Null	15
SUPPL	118	Null	7
SUPPL	119	Null	7
SUPPL	122	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84113
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)