Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020380
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIFFERIN | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/14/2022 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020380Orig1s021lbl.pdf | |
| 03/23/2018 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020380Orig1s013lbl.pdf | |
| 05/19/2017 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020380Orig1s011lbl.pdf | |
| 07/08/2016 | SUPPL-10 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020380Orig1s010lbl.pdf |