NDA 050586

ALLERGAN

FDA Drug Application

Application #050586

Documents

• Letter: 2006-01-19
• Label: 2006-01-05
• Letter: 2006-01-19
• Label: 2006-01-05
• Label: 2017-03-21
• Letter: 2017-03-24
• Label: 2018-06-11
• Letter: 2018-06-14

Application Sponsors

NDA 050586

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

EQ 0.3% BASE;1%

1

PRED-G

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1988-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-07-29	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	1989-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-03-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	1991-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2005-12-20	STANDARD
LABELING; Labeling	SUPPL	26	AP	2005-12-20	STANDARD
LABELING; Labeling	SUPPL	31	AP	2017-03-20	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-06-07	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	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	31	Null	7
SUPPL	32	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50586
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRED-G","activeIngredients":"GENTAMICIN SULFATE; PREDNISOLONE ACETATE","strength":"EQ 0.3% BASE;1%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/07\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050586s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2017","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050586s031lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050586s025s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2005","submission":"SUPPL-25","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050586s025s026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PRED-G","submission":"GENTAMICIN SULFATE; PREDNISOLONE ACETATE","actionType":"EQ 0.3% BASE;1%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-07
        )

)