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Application 018469

Type
NDA
Sponsor
ALCON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BSS PLUSCALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATESOLUTION;IRRIGATION0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent
0065-0800BSS PLUSbalanced salt solution enriched with bicarbonate, dextrose, and glutathioneAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73986SUPPL 2023-04-14
11227SUPPL2016-06-17
932SUPPL2016-04-28
15013SUPPL2015-12-22
931SUPPL2015-12-22
33497SUPPL2015-11-12
11226SUPPL2015-11-12
11225SUPPL2015-05-14
33496SUPPL2004-12-30
11224SUPPL2004-12-30
930SUPPL2004-12-30
929SUPPL2004-12-30
33495SUPPL2004-05-27
33494SUPPL2004-05-27
15012SUPPL2004-05-27
928SUPPL2004-05-27
15011SUPPL2003-07-28
927SUPPL2003-07-28