Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206164
Company: ENCUBE
Company: ENCUBE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
05/23/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |