NDA 019967

SUN PHARM INDS INC

FDA Drug Application

Application #019967

Documents

• Letter: 2004-09-17
• Letter: 2003-04-18
• Letter: 2012-04-04
• Label: 2003-04-07
• Label: 2004-09-17
• Label: 2012-04-02
• Review: 2007-08-06

Application Sponsors

NDA 019967

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

0.05%

1

ULTRAVATE

HALOBETASOL PROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-12-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-12-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-10-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-09-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2012-04-02	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2016-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2016-12-09	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	15	Null	6
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19967
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRAVATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/02\/2012","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019967s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2004","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19967s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2003","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019967s004lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULTRAVATE","submission":"HALOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-04-02
        )

)