NDA 006927

SUN PHARM INDS INC

FDA Drug Application

Application #006927

Documents

• Letter: 2004-06-03
• Letter: 2003-07-06
• Label: 2003-07-08
• Label: 2004-06-03

Application Sponsors

NDA 006927

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

10%

1

EURAX

CROTAMITON

FDA Submissions

UNKNOWN;	ORIG	1	AP	1949-07-06	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1975-11-13
LABELING; Labeling	SUPPL	8	AP	1975-11-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1977-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1977-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1977-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1977-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1977-10-27
LABELING; Labeling	SUPPL	14	AP	1978-10-05
LABELING; Labeling	SUPPL	15	AP	1980-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1979-03-12
LABELING; Labeling	SUPPL	17	AP	1983-09-09
LABELING; Labeling	SUPPL	19	AP	1981-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1982-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1984-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1984-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1984-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1984-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1989-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1987-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2002-05-23
LABELING; Labeling	SUPPL	30	AP	2003-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2013-10-30

Submissions Property Types

SUPPL	7	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	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6927
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EURAX","activeIngredients":"CROTAMITON","strength":"10%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/26\/2003","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/06927slr030,09112slr021_eurax_lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/1982","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/06927slr030,09112slr021_eurax_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"EURAX","submission":"CROTAMITON","actionType":"10%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2003-06-26
        )

)