Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021184
Company: ALMIRALL
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVAGE | TAZAROTENE | 0.1% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
| TAZORAC | TAZAROTENE | 0.05% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
| TAZORAC | TAZAROTENE | 0.1% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/21/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | Label for Avage and Tazorac | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021184s009lbl.pdf |
| 09/16/2016 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | Avage label updated | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021184s008lbl.pdf |
| 12/13/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | Tazorac label updated | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf |
| 09/30/2002 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf | |
| 10/11/2001 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf | |
| 09/29/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21184lbl.pdf |