NDA 012097

DELCOR ASSET CORP

FDA Drug Application

Application #012097

Documents

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

Application Sponsors

NDA 012097

DELCOR ASSET CORP

Marketing Status

• Discontinued: 001

Application Products

001

PASTE;DENTAL

0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

KENALOG IN ORABASE

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1960-03-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	1977-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1977-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1977-05-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	1978-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1979-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1979-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-06-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2002-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1986-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1986-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1990-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1993-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-05-22	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12097
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"KENALOG IN ORABASE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"PASTE;DENTAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/03\/2002","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/12097s16lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KENALOG IN ORABASE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"PASTE;DENTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2002-09-03
        )

)