Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209282
Company: FDC LTD
Company: FDC LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
09/26/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |