Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020485
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VISINE | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.025%;0.3% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/22/2025 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020485Orig1s021lbl.pdf | |
| 10/17/2018 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020485Orig1s013lbl.pdf | |
| 08/26/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020485Orig1s011lbl.pdf | |
| 12/18/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf | |
| 09/15/2003 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20485scm006_visine_lbl.pdf |
| 06/14/2002 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf |