NDA 020092

ALLERGAN

FDA Drug Application

Application #020092

Documents

• Letter: 2003-12-16
• Letter: 2010-06-15
• Letter: 2011-06-09
• Label: 2010-06-24
• Label: 2011-06-27

Application Sponsors

NDA 020092

ALLERGAN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DILACOR XR	DILTIAZEM HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DILACOR XR	DILTIAZEM HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	240MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DILACOR XR	DILTIAZEM HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-05-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	1992-10-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	1997-06-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	1993-12-06	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	1995-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-08-07	STANDARD
LABELING; Labeling	SUPPL	15	AP	2003-12-12	STANDARD
LABELING; Labeling	SUPPL	16	AP	2010-06-08	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2011-06-07	UNKNOWN

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	31
SUPPL	17	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20092
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILACOR XR","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DILACOR XR","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DILACOR XR","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/07\/2011","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020092s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2010","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020092s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DILACOR XR","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DILACOR XR","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DILACOR XR","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"240MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-06-07
        )

)