NDA 017556

SUN PHARM INDS INC

FDA Drug Application

Application #017556

Documents

• Letter: 2004-10-04
• Label: 2009-06-22
• Letter: 2009-06-16
• Label: 2004-10-04

Application Sponsors

NDA 017556

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

1

HALOG

HALCINONIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1974-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1975-05-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	1975-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1976-02-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	1977-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1977-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1978-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1978-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1978-06-07	STANDARD
LABELING; Labeling	SUPPL	16	AP	1978-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1979-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1979-02-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	1980-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1980-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1980-05-20	STANDARD
LABELING; Labeling	SUPPL	23	AP	1982-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1982-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1984-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1985-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1985-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1986-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1986-05-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1987-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1989-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1989-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1990-06-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	2004-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2009-06-10	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2014-04-02	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	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	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	41	Null	0

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17556
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOG","activeIngredients":"HALCINONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/10\/2009","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017556s038lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2009","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017556s038lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17556s034lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HALOG","submission":"HALCINONIDE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-06-10
        )

)