NDA 050612

ALLERGAN

FDA Drug Application

Application #050612

Documents

• Letter: 2003-10-28
• Label: 2017-03-21
• Letter: 2017-03-24
• Label: 2018-06-11
• Letter: 2018-06-14

Application Sponsors

NDA 050612

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;OPHTHALMIC

EQ 0.3% BASE;0.6%

1

PRED-G

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2003-10-22	STANDARD
LABELING; Labeling	SUPPL	20	AP	2017-03-20	STANDARD
LABELING; Labeling	SUPPL	21	AP	2018-06-07	STANDARD

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	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	7
SUPPL	21	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50612
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRED-G","activeIngredients":"GENTAMICIN SULFATE; PREDNISOLONE ACETATE","strength":"EQ 0.3% BASE;0.6%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/07\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050612s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050612s020lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PRED-G","submission":"GENTAMICIN SULFATE; PREDNISOLONE ACETATE","actionType":"EQ 0.3% BASE;0.6%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-07
        )

)