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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018469
Company: ALCON

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BSS PLUS CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML SOLUTION;IRRIGATION Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/27/2016 SUPPL-56 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf
11/06/2015 SUPPL-55 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf
11/06/2015 SUPPL-54 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf
05/29/2013 SUPPL-52 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf
12/20/2004 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf
12/20/2004 SUPPL-40 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf
05/25/2004 SUPPL-39 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf
05/25/2004 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf
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