Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018469
Company: ALCON
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/28/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/13/2023 | SUPPL-60 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018469Orig1s060ltr.pdf |
| 04/27/2016 | SUPPL-56 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018469Orig1s056ltr.pdf | |
| 11/06/2015 | SUPPL-55 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018469Orig1s054, 055ltr.pdf | |
| 11/06/2015 | SUPPL-54 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018469Orig1s054, 055ltr.pdf | |
| 02/09/2015 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2013 | SUPPL-52 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf | |
| 12/20/2004 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469s040,041ltr.pdf | |
| 12/20/2004 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469s040,041ltr.pdf | |
| 05/25/2004 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469SLR038,039ltr.pdf | |
| 05/25/2004 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469SLR038,039ltr.pdf | |
| 07/16/2003 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18469scp036,slr037ltr.pdf |
| 07/16/2003 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18469scp036,slr037ltr.pdf |
| 10/18/1999 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1998 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/02/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/19/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1992 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/24/1989 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/08/1988 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/1993 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1988 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1988 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/1987 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/1987 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1986 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1986 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/14/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1982 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| 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 |