Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202470
Company: CINTEX SVCS
Company: CINTEX SVCS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESONIDE | DESONIDE | 0.05% | GEL;TOPICAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/11/2020 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202470Orig1s000TAltr.pdf |