Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021794
Company: ALMIRALL
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACZONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/18/2018 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf | |
| 05/18/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf | |
| 07/09/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf | |
| 03/26/2009 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
| 03/26/2009 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
| 03/14/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf | |
| 07/07/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf |