FDA Approval for TWYNEO issued to SOL-GEL TECHNOLOGIES LTD
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 214902
Company: SOL-GEL TECHNOLOGIES LTD
Company: SOL-GEL TECHNOLOGIES LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TWYNEO | TRETINOIN;BENZOYL PEROXIDE | 0.1%;3% | CREAM;TOPICAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/26/2021 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214902s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/26/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214902s000lbl.pdf |