NDA 009112

SUN PHARM INDS INC

FDA Drug Application

Application #009112

Documents

• Letter: 2003-07-06
• Letter: 2009-07-15
• Label: 2003-07-08

Application Sponsors

NDA 009112

SUN PHARM INDS INC

Marketing Status

• Prescription: 003

Application Products

003

LOTION;TOPICAL

10%

1

EURAX

CROTAMITON

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1955-04-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	1983-09-09
LABELING; Labeling	SUPPL	7	AP	1981-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-03-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-04-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-05-23	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2009-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2014-10-08	STANDARD

Submissions Property Types

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	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	0

TE Codes

003

Prescription

AT

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9112
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EURAX","activeIngredients":"CROTAMITON","strength":"10%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/26\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/06927slr030,09112slr021_eurax_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EURAX","submission":"CROTAMITON","actionType":"10%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2003-06-26
        )

)