Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050819
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACANYA | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | AB | Yes | Yes |
| ONEXTON | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 3.75%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/11/2025 | SUPPL-29 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050819Orig1s029lbl.pdf |
| 02/21/2020 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 02/21/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 02/21/2020 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 02/21/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 11/24/2014 | SUPPL-12 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf | |
| 02/28/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf | |
| 10/18/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf | |
| 06/23/2010 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf | |
| 10/23/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf |