NDA 018469

ALCON

FDA Drug Application

Application #018469

Documents

• Letter: 2003-07-28
• Letter: 2004-05-27
• Letter: 2004-12-30
• Letter: 2004-12-30
• Letter: 2015-12-22
• Letter: 2016-04-28
• Label: 2004-12-30
• Label: 2015-05-14
• Label: 2015-11-12
• Label: 2016-06-17
• Letter: 2003-07-28
• Letter: 2004-05-27
• Letter: 2015-12-22
• Label: 2004-05-27
• Label: 2004-05-27
• Label: 2004-12-30
• Label: 2015-11-12

Application Sponsors

NDA 018469

ALCON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

1

BSS PLUS

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1981-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-06-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	1988-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-10-24	STANDARD
LABELING; Labeling	SUPPL	21	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1990-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1992-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1991-12-30	STANDARD
LABELING; Labeling	SUPPL	27	AP	1993-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1994-08-19	STANDARD
LABELING; Labeling	SUPPL	29	AP	1994-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1997-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1997-05-02	STANDARD
LABELING; Labeling	SUPPL	32	AP	1998-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1997-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1998-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1999-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2003-07-16	STANDARD
LABELING; Labeling	SUPPL	37	AP	2003-07-16	STANDARD
LABELING; Labeling	SUPPL	38	AP	2004-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2004-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2004-12-20	STANDARD
LABELING; Labeling	SUPPL	41	AP	2004-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2013-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2015-02-09	STANDARD
LABELING; Labeling	SUPPL	54	AP	2015-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2015-11-06	STANDARD
LABELING; Labeling	SUPPL	56	AP	2016-04-27	STANDARD

Submissions Property Types

SUPPL	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	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	9
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	15
SUPPL	55	Null	0
SUPPL	56	Null	15

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18469
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"BSS PLUS","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE","strength":"0.154MG\/ML;0.92MG\/ML;0.184MG\/ML;0.2MG\/ML;0.38MG\/ML;2.1MG\/ML;7.14MG\/ML;0.42MG\/ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/27\/2016","submission":"SUPPL-56","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018469s056lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2015","submission":"SUPPL-55","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018469s054s055lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/06\/2015","submission":"SUPPL-54","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018469s054s055lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2013","submission":"SUPPL-52","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018469s052lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/20\/2004","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18469s040,041lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2004","submission":"SUPPL-40","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18469s040,041lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2004","submission":"SUPPL-39","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18469SLR038,039_bss_lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2004","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18469SLR038,039_bss_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BSS PLUS","submission":"CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE","actionType":"0.154MG\/ML;0.92MG\/ML;0.184MG\/ML;0.2MG\/ML;0.38MG\/ML;2.1MG\/ML;7.14MG\/ML;0.42MG\/ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-04-27
        )

)