NDA 050091

ALLERGAN

FDA Drug Application

Application #050091

Documents

• Label: 2003-05-02

Application Sponsors

NDA 050091

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

CHLOROPTIC

CHLORAMPHENICOL

FDA Submissions

	ORIG	1	AP	1968-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1969-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-12-02
LABELING; Labeling	SUPPL	7	AP	1989-04-05
LABELING; Labeling	SUPPL	8	AP	2000-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1972-02-11
LABELING; Labeling	SUPPL	12	AP	1971-11-22
LABELING; Labeling	SUPPL	13	AP	1974-01-18
LABELING; Labeling	SUPPL	14	AP	1974-05-20
LABELING; Labeling	SUPPL	15	AP	1974-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1974-11-14
LABELING; Labeling	SUPPL	17	AP	1974-11-26
LABELING; Labeling	SUPPL	18	AP	1975-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1975-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1976-02-03
LABELING; Labeling	SUPPL	22	AP	1976-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1976-07-20
LABELING; Labeling	SUPPL	24	AP	1976-10-13
LABELING; Labeling	SUPPL	25	AP	1976-12-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1977-02-15
LABELING; Labeling	SUPPL	27	AP	1977-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1979-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1979-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1979-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1980-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1982-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1996-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1997-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1997-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2000-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2001-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2001-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2001-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2002-04-12

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50091
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLOROPTIC","activeIngredients":"CHLORAMPHENICOL","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/2001","submission":"SUPPL-40","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50091s40lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"CHLOROPTIC","submission":"CHLORAMPHENICOL","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-01-30
        )

)