Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203790
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| 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 |
|---|---|---|---|---|---|---|---|
| 09/30/2015 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000ltr.pdf |