NDA 020508

SUN PHARM INDS INC

FDA Drug Application

Application #020508

Documents

• Label: 2004-12-30
• Review: 2001-12-11
• Letter: 2000-08-25
• Letter: 2004-12-22
• Label: 2000-08-25

Application Sponsors

NDA 020508

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

LAC-HYDRIN

AMMONIUM LACTATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-07-19	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2000-08-25	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2004-12-13	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	8

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20508
            [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LACTATE","strength":"EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/13\/2004","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20508s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2000","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20508S5lbl.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LACTATE","actionType":"EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-12-13
        )

)