NDA 018726

SUN PHARM INDS INC

FDA Drug Application

Application #018726

Documents

• Letter: 2002-09-03
• Letter: 2000-09-21
• Label: 2002-09-03
• Label: 2002-09-03

Application Sponsors

NDA 018726

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;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0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 3; Type 3 - New Dosage Form	ORIG	1	AP	1983-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-02-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2002-09-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2002-09-03	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18726
            [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VALERATE","strength":"0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/03\/2002","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18726s9s12lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2002","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18726s9s12lbl.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VALERATE","actionType":"0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2002-09-03
        )

)