NDA 019155

SUN PHARM INDS INC

FDA Drug Application

Application #019155

Documents

• Letter: 2004-05-03
• Letter: 2007-11-19
• Label: 2007-11-19
• Letter: 2004-05-03
• Review: 2007-07-06
• Review: 2007-07-06

Application Sponsors

NDA 019155

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

LOTION;TOPICAL

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

LAC-HYDRIN

AMMONIUM LACTATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1985-04-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-08-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	1986-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-05-20	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-04-28	STANDARD
LABELING; Labeling	SUPPL	20	AP	2004-04-28	STANDARD
LABELING; Labeling	SUPPL	22	AP	2007-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2013-04-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	30	Null	0

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19155
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAC-HYDRIN","activeIngredients":"AMMONIUM LACTATE","strength":"EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/09\/2007","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019155s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LAC-HYDRIN","submission":"AMMONIUM LACTATE","actionType":"EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2007-11-09
        )

)