NDA 019700

ALLERGAN

FDA Drug Application

Application #019700

Documents

• Letter: 2005-03-11
• Letter: 2012-06-18
• Label: 2003-06-16
• Label: 2005-03-11
• Label: 2012-06-18
• Letter: 2002-02-08
• Letter: 2005-03-11
• Review: 2009-01-12
• Label: 2002-02-08
• Label: 2005-03-11

Application Sponsors

NDA 019700

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

1

ACULAR

KETOROLAC TROMETHAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-03-29	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1996-09-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	1996-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-07-11	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1996-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-02-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2001-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-07-16	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2002-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2005-03-10	STANDARD
LABELING; Labeling	SUPPL	24	AP	2005-03-10	STANDARD
LABELING; Labeling	SUPPL	28	AP	2012-06-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	8
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	7

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19700
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACULAR","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/14\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019700s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2005","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/19700S023,024lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2005","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/19700S023,024lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2002","submission":"SUPPL-19","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19700s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2001","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19700s18lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"ACULAR","submission":"KETOROLAC TROMETHAMINE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-06-14
        )

)