NDA 017950

SUN PHARM INDS INC

FDA Drug Application

Application #017950

Documents

• Letter: 2003-03-25
• Label: 2003-03-25

Application Sponsors

NDA 017950

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

WESTCORT

HYDROCORTISONE VALERATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1978-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1980-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1980-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-09-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	1983-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1981-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1986-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-11-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-03-24	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	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

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17950
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"WESTCORT","activeIngredients":"HYDROCORTISONE VALERATE","strength":"0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/24\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/17950slr021_westcort_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"WESTCORT","submission":"HYDROCORTISONE VALERATE","actionType":"0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2003-03-24
        )

)