NDA 020742

ALCON

FDA Drug Application

Application #020742

Documents

• Letter: 2003-05-29
• Letter: 2004-05-26
• Label: 2003-07-10
• Label: 2004-05-27
• Label: 2004-10-04
• Letter: 2003-07-10
• Letter: 2004-05-26
• Letter: 2004-10-04
• Letter: 2009-04-29
• Letter: 2015-12-22
• Letter: 2015-12-22
• Label: 2003-04-28
• Label: 2004-05-27
• Label: 2015-11-12
• Label: 2015-11-12

Application Sponsors

NDA 020742

ALCON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

1

BSS

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1997-12-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2003-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2003-04-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2004-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2004-05-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2004-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2009-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2012-11-15	STANDARD
LABELING; Labeling	SUPPL	25	AP	2015-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2015-11-06	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	0
SUPPL	5	Null	9
SUPPL	6	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	15
SUPPL	26	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20742
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"BSS","activeIngredients":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","strength":"0.48MG\/ML;0.3MG\/ML;0.75MG\/ML;3.9MG\/ML;6.4MG\/ML;1.7MG\/ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/06\/2015","submission":"SUPPL-26","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020742s025s026lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/06\/2015","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020742s025s026lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2004","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20742s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2004","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20742slr005,scp006_bss_lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2004","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20742slr005,scp006_bss_lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2003","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20742slr003_aqualase_lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2003","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020742s004lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BSS","submission":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","actionType":"0.48MG\/ML;0.3MG\/ML;0.75MG\/ML;3.9MG\/ML;6.4MG\/ML;1.7MG\/ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-11-06
        )

)