NDA 019968

SUN PHARM INDS INC

FDA Drug Application

Application #019968

Documents

• Letter: 2012-04-04
• Label: 2004-09-17
• Letter: 2004-09-17
• Label: 2012-04-02

Application Sponsors

NDA 019968

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

1

ULTRAVATE

HALOBETASOL PROPIONATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-07-12	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-09-17	STANDARD
LABELING; Labeling	SUPPL	11	AP	2012-04-02	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-05-17	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	11	Null	7
SUPPL	12	Null	0

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19968
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRAVATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/02\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019968s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2004","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19968s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULTRAVATE","submission":"HALOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-04-02
        )

)