ANDA 083386

UPSHER SMITH LABS

FDA Drug Application

Application #083386

Application Sponsors

ANDA 083386

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1974-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1984-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1984-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1984-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1986-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1986-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1986-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1988-04-14
LABELING; Labeling	SUPPL	55	AP	1988-03-08
LABELING; Labeling	SUPPL	57	AP	1988-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1988-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1989-04-14
LABELING; Labeling	SUPPL	60	AP	1990-11-29
LABELING; Labeling	SUPPL	61	AP	1991-12-31
LABELING; Labeling	SUPPL	62	AP	1992-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1996-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1999-03-22
LABELING; Labeling	SUPPL	65	AP	1999-03-22
LABELING; Labeling	SUPPL	66	AP	2002-11-25
LABELING; Labeling	SUPPL	81	AP	2008-11-19
LABELING; Labeling	SUPPL	84	AP	2009-08-18
LABELING; Labeling	SUPPL	87	AP	2010-12-03
LABELING; Labeling	SUPPL	90	AP	2011-09-13
LABELING; Labeling	SUPPL	94	AP	2016-08-29	STANDARD
LABELING; Labeling	SUPPL	95	AP	2017-02-23	STANDARD
LABELING; Labeling	SUPPL	98	AP	2020-02-05	STANDARD

Submissions Property Types

SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	84	Null	7
SUPPL	87	Null	7
SUPPL	90	Null	15
SUPPL	94	Null	15
SUPPL	95	Null	15
SUPPL	98	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83386
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)