Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050790
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESTASIS | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | AB | Yes | Yes |
| RESTASIS MULTIDOSE | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/21/2025 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050790s031lbl.pdf | |
| 07/18/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf | |
| 10/27/2016 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf | |
| 10/27/2016 | SUPPL-24 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf |
| 05/31/2013 | SUPPL-21 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050790s021lbl.pdf |
| 12/03/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf | |
| 09/16/2003 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50790slr001_restasis_lbl.pdf | |
| 12/23/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050790lbl.pdf |