Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020742
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BSS | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION;IRRIGATION | Prescription | AT | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/06/2015 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf |
| 11/06/2015 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf | |
| 09/30/2004 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf | |
| 05/25/2004 | SUPPL-6 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf | |
| 05/25/2004 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf | |
| 07/09/2003 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf | |
| 04/15/2003 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020742s004lbl.pdf |