FDA.reportPublic FDA data

Application 020742

Type
NDA
Sponsor
ALCON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BSSCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATESOLUTION;IRRIGATION0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-0795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-0795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-0795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-0795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-0795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-1795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-1795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-1795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-1795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent
0065-1795BSSbalanced salt solutionAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
25674SUPPL2015-12-22
25673SUPPL2015-12-22
35257SUPPL2015-11-12
35256SUPPL2015-11-12
25672SUPPL2009-04-29
25671SUPPL2004-10-04
13328SUPPL2004-10-04
35255SUPPL2004-05-27
13327SUPPL2004-05-27
25670SUPPL2004-05-26
3246SUPPL2004-05-26
25669SUPPL2003-07-10
13326SUPPL2003-07-10
3245SUPPL2003-05-29
35254SUPPL2003-04-28