Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200480
Company: SEPTODONT
Company: SEPTODONT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DYCLOPRO | DYCLONINE HYDROCHLORIDE | 0.5% | SOLUTION;TOPICAL | Prescription | None | No | Yes |
DYCLOPRO | DYCLONINE HYDROCHLORIDE | 1% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
11/20/2018 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |