NDA 018117

ABBVIE

FDA Drug Application

Application #018117

Documents

• Letter: 2003-09-25
• Letter: 2003-12-23
• Letter: 2004-01-09
• Letter: 2006-09-18
• Letter: 2008-03-17
• Label: 2003-09-25
• Label: 2003-12-29
• Label: 2008-03-17
• Letter: 2007-04-20
• Review: 2004-05-27
• Label: 2007-04-20
• Label: 2004-01-15

Application Sponsors

NDA 018117

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

0.1MG/INH

0

AZMACORT

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1982-04-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	1984-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-03-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	1984-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1990-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1992-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1990-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1996-11-21	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	1996-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-07-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1997-06-12	STANDARD
LABELING; Labeling	SUPPL	29	AP	1999-02-08	STANDARD
LABELING; Labeling	SUPPL	30	AP	2007-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-08-17	STANDARD
LABELING; Labeling	SUPPL	32	AP	2003-09-04	STANDARD
LABELING; Labeling	SUPPL	33	AP	2003-12-18	STANDARD
LABELING; Labeling	SUPPL	34	AP	2003-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2006-09-05	STANDARD
LABELING; Labeling	SUPPL	42	AP	2008-03-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	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	22	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	31	Null	0
SUPPL	37	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18117
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZMACORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/13\/2008","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018117s042lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2007","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018117s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2003","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/18117slr034_azmacort_lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/18117slr033_azmacort_lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2003","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/18117slr032_azmacort_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AZMACORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2008-03-13
        )

)